Passive safety intraosseous device

ABSTRACT

A portable and passive safety intraosseous device to allow for direct introduction of medications, etc., within the intermedullary space of a subject patient&#39;s bone or, if needed, the removal of certain substances from such a subject patient&#39;s bone. Such a device permits direct drilling and placement of a cannula within the subject bone with access external to the subject patient&#39;s skin, permitting, as well, connection of a tube for such introduction/removal purposes. The ability to provide a passive safety unit allows for facilitated utilization in, for instance, emergency situations with the entire device provided for utilization thereof. The device includes a drilling component with a permanently attached stylet and a removable cannula, a power supply for a single drilling operation, a mechanism to draw the stylet back into the drill component after use and disengagement from the cannula, and an automatic closure that activates with the separation of the cannula.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of pending U.S. patentapplication Ser. No. 16/125,767, filed on Sep. 10, 2018, which claimsthe benefit of expired U.S. Provisional Patent Application Nos.62/556,397, filed on Sep. 9, 2017, and 62/566,498, filed on Oct. 1,2017. The entirety of the parent application and both provisionalapplications are herein incorporated by reference.

FIELD OF THE INVENTION

The disclosure relates to a portable and passive safety intraosseousdevice to allow for direct introduction of medications, etc., within theintermedullary space of a subject patient's bone or, if needed, theremoval of certain substances from such a subject patient's bone. Such adevice permits direct drilling and placement of a cannula within thesubject bone with access external to the subject patient's skin,permitting, as well, connection of a tube for such introduction/removalpurposes. The ability to provide a passive safety unit allows forfacilitated utilization in, for instance, emergency situations with theentire device provided for utilization thereof. The device includes adrilling component with a permanently attached stylet and a removablecannula, a power supply for a single drilling operation, a mechanism todraw the stylet back into the drill component after use anddisengagement from the cannula, and an automatic closure that activateswith the separation of the cannula.

BACKGROUND OF THE INVENTION

The ability to internally deliver fluids and/or medicaments to a patientfor quick and effective resolution of certain medical problems has, ofcourse, been the desire of the medical industry since its inception.Although intravenous delivery is a standard for certain situations,there are emergency instances that require a much more robust and saferprocedure than first having access to an individual's arm or neck andthen, in a potentially difficult position, undertaking venipuncture toprovide such an IV line. One particularly effective alternative to suchIV-based methods is intraosseous delivery, or the access to theintramedullary space of certain properly sized and located bones withina subject patient's body. For example, again, considering emergencysituations in particular, there may occur the need to access a properintroductory space for a patient at an automobile accident site. Such apatient may be suffering from cardiac arrest or other type of malady atthat moment requiring quick action to introduce necessaryfluids/medicaments for treatment. With an IV-based procedure, again, ifthe patient is situated in a difficult position for such IV access, orat least in terms of access at a proper and suitable vein for such apurpose, the ability to provide such a necessary action may becompromised. Finding the vein, for instance, may be difficult andrequire multiple attempts by the emergency medical technician, incurringtime that is of enormous necessity. Thus, there is an alternative thatmay provide more access points for such fluid/medicament delivery. Suchintraosseous processes allow the paramedic, clinician, EMS personnel,etc. the ability to locate a suitable bone (whether in the arm, leg,knee, or even sternum) and then introduce a cannula therein for deliveryof needed fluid/medicament within the intermedullary space thereof. Sucha procedure has proven to be an effective alternative to IV methods onoccasion, but in terms of emergency access situations, and the ability,at least, to introduce fluid/medicament within a bone that is close to,for instance, a patient's heart, is particularly effective and desired.Additionally, such an intraosseous method may also permit removal of,for example, blood plasma, bone marrow, and the like, in less stressfulsituations than emergencies. In any event, the versatility of such adevice is particularly important and aids immeasurably within themedical industry as a result.

To date, there have been utilized certain intraosseous devices todifferent levels of effectiveness and versatility. Initially, the“standard” method employed was basically the manual screwing in of acannula and stylet. Such a method is, clearly, dependent upon theabilities of the user to first determine the proper location for such anintroduction and, more importantly, the need to properly gauge the depthof such a drilling/screwing stylet component to enter the subjectpatient's bone. Guides may be provided at the skin surface for somedegree of control and depth determinations, but the ability to properlyoperate and apply such a manual device has not proven effective and/ordesirous in developed nations. Certainly, though, the ability to providesome type of manual intraosseous device in other countries that lackaccess to battery, etc., powered devices leaves the usefulness of such adevice to the capabilities of the actual user and whether s/he cancontrol and direct such a screw-type implement correctly. Relative speedof introduction is likewise then a potential drawback of this type ofdevice.

Other devices, such as spring-loaded ballistic types have also beenemployed within the industry. Such gun-like delivery devices are,frankly, limited in their benefits to the industry simply because theuser must properly hold and aim such a device while it basically shootsa cannula device through a subject patient's skin and into his or herbone. The user must align everything properly, hope that the cockeddevice does not prematurely shoot the sharp cannula component, and thenkeep the device in place while shooting a sharp dart-like implement intothe desired bone. Such a method has proven highly suspect at theemergency use level, primarily because of the difficulties in keepingthe alignment, etc., in place correctly and, more importantly, the lackof control of the depth of introduction within the subject bone. Ifemployed with certain target bones, such a “shot” dart may crack certainbones, potentially causing potential problems such as leakage ofintramedullary fluids or, more importantly, introduction within the boneof undesirable substances (not to mention significant pain for thesubject patient, too). Additionally, such a device may misfire, hittingundesired locations, may dislodge from a patient's bone readilyparticularly when the stylet is removed, or even fail to penetrate thetarget bone. As such, the drawbacks of this type of intraosseous deviceare prevalent.

Another device utilized currently includes a separate drill componentthat magnetically attaches to a stylet (trochar)/cannula implement.Whether utilizing this magnetic drill option or the projecting type, thestylet/cannula combination has proven to be highly effective due to theability of the stylet to generate the primary bone entry results(drilling or shooting) with a proper tapered end while being removablefrom the cannula thereafter. This configuration allows for the stylet todrill, shoot, penetrate, etc., while preventing bone, skin, and fluidfrom clogging the cannula upon removal therefrom. It thus also allowsthe cannula to be of a suitable bore to provide optimum injection (drip)into or removal from the subject bone intermedullary space. In otherwords, the combination of stylet and cannula has proven to be importantand highly desirable for intraosseous utilization.

Thus, with the magnetically attached stylet/cannula device, such is thenplaced at a location external of a subject patient and aligned with alocation for a suitable bone and then the drill is activated tointroduce the stylet therein. After drilling, the stylet is detachedfrom the drill (which is then used for future drilling procedures) andthen unscrewed from the cannula, leaving an access port for fluid, etc.,introduction therein through the recessed cannula, fluid, etc., and/orremoval from the same port. To accommodate different bone sizes and/ordifferent size subject patients (adults as compared with young childrenand/or infants, for instance), this system includes two differentlysized stylet/cannula implements (color coded as well), one at 45millimeters and the other at 25 millimeters in length (with 15millimeters for pediatric usage). The cannula includes an externalcircular lip to prevent further introduction within the subjectpatient's skin and bone and a further separator may be placed prior todrilling to further limit the depth of introduction, as well (one may beplaced after drilling, too, to best ensure the cannyula remains inplace). Such a system has proven effective in certain situations,particularly with hospital-based, non-emergency instances due to thecontrol aspects involved and the ability to capture and easily disposeof the stylet post-drilling. There are, however, significant drawbackswith such devices and procedures, namely the requirement for effectivecontrol prior to skin introduction; instances have occurred where theuser attempts to set the stylet properly at the skin surface only tolose control and impale or at least scar the subject patient, even innon-emergency situations. Also, the necessity of handling the extremelysharp stylet has proven difficult and hazardous, particularly afterdetachment from the cannula and most particularly in emergencysituations. As such an implement must be disposed of immediately, forobvious reasons, the potential for the user to harm the patient of her-or him-self is exacerbated with a free stylet in such an instance.Likewise, then, the dependence upon the drill component itself to befully charged for use, if not also provided and/or found easily for sucha purpose, is of significance as well. The separate provision of a drillin this type of situation, coupled with the determination of properlength stylet/cannula, locating such proper length stylet/cannula,attaching same to the drill, and then drilling with all in place withoutharming the subject patient, is of consequence within this particulararea of the medical industry.

Of further importance, if not the highest importance, however, is thatwhether in terms of the projectile or magnetically attached drill type(or any other types within the prior art, including spring-loadeddrills, sternum-applied drilling stylet/cannula implements, etc.) thereis always an issue related to the potential for contamination of thestylet and high potential for contact with a user, patient, or otherbystander during utilization. In other words, and as examples, with thestandard projectile and magnetically attached stylet/cannula drilldevices, there is a requirement of the user to physically detach theused stylet from the cannula and remove the same with thedrilling/shooting tip exposed thereafter without proper coverage. Theonly possible means to prevent contamination appears to be the potentialprovision of a cushion-like implement to insert the stylet tapered endinto after such use. However, in any situation typically provided as oftoday, the lack of automatic coverage and requirement of active removalwith such exposure, no matter how prolonged it may be, leaves too muchof a chance for transfer of contamination. As such, there remains a needfor a truly passive safety protocol that is nonexistent within theintraosseous device market today.

Furthermore, with the reusable drill implement of the magneticallyattached stylet/cannula method and device, such a drill is potentiallycontaminated after each use. Additionally, in emergency situations, sucha magnetically attached device requires the actual locating of,unpacking of, and applying (attaching) of such a stylet/cannulaimplement to a potentially previously contaminated and potentiallyquestionable power level for sufficient operation, such that cleardifficulties in utilization thereof exist. There thus exists asignificant need to provide an intraosseous device and system thatovercomes all of these clear deficiencies. To date, however, theseparate drill with detachable stylet/cannula has been the standard,leaving much to be desired, particularly as an emergency medical tooland specifically in terms of a passive safety protocol.

ADVANTAGES AND BRIEF SUMMARY OF THE INVENTION

A distinct advantage of the versatile apparatus now disclosed is theprovision of a drill with stylet/cannula implement that exhibits totalpassive safety to avoid any potential exposure to contaminatedcomponents subsequent to application of the cannula within a targetpatient's bone. Another advantage includes the ability to provide apotentially disposable drill/stylet combination that accords the abilityto have the entirety of the device provided as a single portablestructure, thus eliminating the need to locate separate component partsprior to utilization and simplified disposal of the same. Anotheradvantage is the ability to provide a drill component that has a propershape that allows for facilitated manual operation for stylet/cannulaintroduction if needed. Yet another advantage is the ability of thestylet to be retracted back within the drill subsequent to drillingcompletion and detachment from the cannula. Still another advantage ofthe overall device and system is the potential for a sensor to determinethe exact moment of entry within the intermedullary space of a subjectbone, thus eliminating the possibility of such a device from enteringsuch a space too far or not far enough, maximizing the amount of spacesuch a device permits fluid introduction and/or removal from the subjectbone. Another advantage is the ability to store the device without anyelectrical contacts and thus the ability to conserve battery power untilutilized, with the potential, as well, to remove any such batterieseasily after use for disposal thereof and placement of the remainingdevice portions within a proper disposal container associated withbodily fluid, and the like, contacted articles. Yet another advantage isthe ability to manually activate the device for electrical connectionand subsequent movement of an internally stored permanently attachedstylet and combined removable needle. Still another advantage is theprovision of a recessed hub on the needle with an recessed lock betweenthe drill-attached stylet and needle. Yet another advantage is thefacilitation of utilization from transport to disposal, including easilytransporting such a device in a pocket or bag, removing it in total,unwrapping from a sealed package, flipping open the device with onehand, manually moving the motor/stylet/cannula sled for external access,operating the drill component to introduce the style/cannula within asubject patient's bone, upon completion, turning the device a quarter(or other degree) turn dislodging and retracting the motor/stylet backinto the device with an automatic cover over the stylet point,subsequently dismantling the device for placement in a sharps containerand otherwise disposal of the remainder. Still another advantage of apotential embodiment is the ability to provide a light within the devicefor visilibity purposes as well as a possible indicator of properelectrical connections upon engagement between the handle and barrel.Still another advantage is a potential embodiment wherein the handleportion of the device is configured to stand upright on its own and withthe barrel attached and manipulated to any angle of rotation around thehandle/barrel connector, and the ability of the light (or lights) toremain in operation as the device stands on its own and with the barrelrotated to different angles. Yet another advantage is the potentialembodiment of the provision of a protective cap within the barrel overthe motor/stylet/cannula that also functions as a extension externallyto allow for sufficient space for a user to effectively grasp thecannula hub as it has penetrated a subject patient's skin and bone, andthat remains extended subsequent to motor/stylet retraction as a mannerof preventing full closure of the device handle back to its originalstored position. Still another advantage is a potential embodimentincluding a protective cap with an extending tab that correlates withopenings within the barrel of the device to both serve as an indicatorof location of the cap (prior to and after device utilization) as wellas a detent to prevent retraction of the cap upon activation of theretraction operation for the motor/stylet.

Accordingly, the inventive intraosseous device comprises a disposabledrill/stylet combination, wherein said drill includes a styletretraction port therein, a retracting mechanism attached to said styletand disposed within said drill, and a cannula connected in detachablerelation to said stylet, wherein said stylet is permanently attached tosaid drill, wherein said retracting mechanism operates subsequent toutilization of said drill to introduce said stylet and cannula withinthe intermedullary space of a subject bone, said retracting mechanismmoving said stylet from an external location to said stylet retractionport within said drill subsequent to a drilling operation, and whereinsaid cannula is attached to said drill with a Luer lock component with alip portion present external to said drill and an automatic closureinternally within said drill that activates upon disengagement of saidcannula from said drill. The external lip of the cannula also provides,if needed, a surface for a user to grab while maneuvering the drill.Also encompassed herein is the inclusion of a sensor on said stylet,wherein said sensor measures pressure subsequent to bone entry such thatonce passed through to said intermedullary space the pressure differencedeactivates the drill and activates the retraction mechanism anddetaching from said cannula. The method of utilization of such a device(with or without the sensor as described) is also encompassed hereinwherein the cannula as retained within the bone and skin and accessingsaid intermedullary space of the subject bone allows for introduction orremoval of fluid, etc., therein.

Alternatively, the overall device may be provided with an internalmovable combination of a stylet and cannula that are not directlyconnected, but are co-connected through a rotatable base. In such aconfiguration, the stylet may, for instance, be integrated within such abase in that it may be permanently affixed thereto and aligned with theopening shaft of the cannula so as to egress out of the top with thetapered end available for drill purposes. The cannula may then beattached to such a base through an two or more outer arm extensions fromthe base that include flanges that insert and turn within complementarystructures on the base of the cannula in order to allow simultaneouslyfor temporary attachment (and detachment through turning of the internaldrill device base a specific distance after drilling has been completed)and rotation of the cannula in concert with the stylet. The movablenature allows for a stationed motor and gear box within the housing ofthe drill device with the extendible stylet/cannula combination arrangedto retain gear association with the motor and gear box (to permit suchrotation for drilling results) while allowing as well for retraction ofthe stylet once drilling has been effectuated. In addition, an internalseal (or door) may be provided initially to ensure the internal styletand cannula are protected from contamination prior to use; if so, such adoor may be configured to move and thus open to provide an egress pointthrough the distal end of the drill device for the stylet/cannulacombination to exit for drilling to commence. At the same time, anopposing door/seal component may be primed upon such extension in orderto automatically close upon retraction of the stylet after use and/orupon detachment of the cannula from the internal extendible base (andthus from the drill device itself). In this manner, the passive safetynecessity is provided in an alternative manner but still as effective,if not more effective, than the prior disclosure above. The user merelyactivates the internal base extension to open the drill egress point forthe stylet/cannula to exit, activate the motor to effectuate the gearbox and extended gear shaft to rotate the stylet and cannulasimultaneously for drilling within a target patient's skin and boneuntil entering the target intermedullary space thereof, stopping such adrilling action, rotating the drill a slight turn to disengage thecannula from the base, at which point the stylet and internal basereturn automatically within the drill device and the primed door/sealcloses automatically as well, leaving only the cannula with its Luerlock end available for attachment with an IV line or like implement asneeded for fluid, etc., introduction or material, etc., removal from thetarget intermedullary bone space. If further desired, the user mayinclude the application of a disinfectant on the Luer lock tip tofurther ensure contamination is not an issue.

The disclosed device may alternatively include a cannula with a hub forIV or other connection/insertion (again, for medicament, drug, fluid,etc., delivery within a subject patient's bone) that itself utilizes anovel recessed attachment point, rather than an extended Luer lock tip.Such a recessed configuration would allow for stylet temporaryengagement during operation of the intraosseous mechanical automateddrill motor, would facilitate disengagement through device (and thusretained stylet) rotation subsequent to insertion/penetration withinsuch a patient's target bone, and further would allow for the IV, etc.,placement and connection. Such a recessed configuration would ostensiblyprevent undesirable contact, accidentally or otherwise, externally thatcould harm the patient and/or cause dislodgement or damage to the IV,etc., connection itself. In other words, standard Luer lockconfigurations extend outwardly from a standard cannula hub, requiringthe IV, etc., connection at a point a measured distance external fromthe hub itself. Such a distance has been known to be rather susceptibleto contact with surfaces and objects through patient movement, at least.As a result, there has been a rather important, yet unmet, need withinthe industry to supply a suitable structure to accommodate such neededmodifications. The typical IV, etc., lines are actually configuredthemselves with a bend at the Luer lock tip to allow for the connectionwith the extended attachment point (for reliable connection), thusproviding a transfer line that may exhibit problematic pressuredifferentials, even possible clogging, at the bend itself. In any event,although a recessed hub configuration as disclosed herein may stillutilize a bent IV, etc., line for such a purpose, it has been realizedthat a direct line may be employed as the connection at the recessedportion allows for any type of connection to be in place in reliablefashion. As it is, the ability to provide greater versatility andprotection from unwanted external contacts allowed with such a recessedcannula hub are at least a few unexpected results of such an improvedstructural aspect of the overall disclosure. Additionally, however, sucha recessed cannula hub allows for, again, a reliable stylet interfacefor effective high-speed rotation while engaged for proper bone drillingfrom the stylet-integrated motor.

Furthermore, as it concerns the recessed cannula hub, such a componentof the overall intraosseous device disclosed herein accords the user asuitable structure to grasp prior to, during, and/or subsequent todrilling of a target bone to allow for effective directional placementand ultimate retraction rotation of the drilling device in relation tothe cannula component. Basically, a user may need to ensure properplacement prior to drilling and the cannula hub allows for such manualmanipulation at the cannula location. During drilling, the ability toassure the direction of the drill is retained, and subsequent thereto,to allow for the device to rotate in the opposite direction, such as aquarter turn, as one non-limiting example, and thus ensuring the cannuladoes not also rotate with the device, all require the accessibility ofthe hub to the user to keep the hub and thus cannula substantiallystill. The hub also may be provided with other accessories attachedthereto to aid, in one non-limiting example, with adhering the cannulain place on a target patient's skin while inserted within such aperson's bone. To that end, the recessed cannula hub, which may,preferably, at least, itself be drilled to be flush with the targetpatient's skin, include opposing wing flaps with, again, as merely onenon-limiting example, a living (or like) hinge at or near the externaledge of the cannula hub, thereby allowing the same to fold downward andextend from the hub to the patient's skin. These wings may be of anygeometric shape as long as they allow for such skin placement.Preferably such wings (or flaps) are roughly rectangular in shape and asunfolded on the patient's skin surface on either side of thesurface-located cannula hub, provide structures that may be taped downto the target skin in order to further engage and secure the cannula(needle) within the target patient's bone. In other words, suchjuxtaposed wings (flaps) allow for an integrated structure within therecessed cannula hub to facilitate retention of the needle componentwithin the target patient to percent unwanted movement from the setbone-insertion position, at least. The recessed cannula hub itself maybe of any geometric shape itself, including circular, oval, square,rectangular, star-shaped, triangular, pentagonal, hexagonal, etc.Additionally, the dimensions are the recessed cannula hub may be of anypermissible width (e.g., diameter) such as from 2-5 centimeters,preferably about 2 cm, and any permissible height (measured from abottom edge to a top edge, with the bottom edge intended to besubstantially flush with the target patient's skin) such as from 1.5-3.5centimeters, preferably about 2 cm. The recessed cannula hub may also beprovided in different colors to indicate the length of the needle(cannula) inserted within a target patient. This communicationcapability helps indicate to, for instance, hospital personnel the typeof cannula (needle) in place as inserted by, again, for instance, anemergency medical technician at an accident site. In other words, theindication of the color of the recessed hub subsequent to insertionwithin a target patient's bone communicates such information directly toa nurse, doctor, etc., within a hospital setting, thus allowing forimmediate recognition and understanding as to the length and possiblybore of the cannula needle in place at that moment. Such colors mayrefer to lengths such as, for instance, yellow pigment to indicate 45 mmneedles, blue pigment for 25 mm needles, and fuchsia (or dark pink)pigment for 15 mm needles (and generally for infant patients). As it is,then, such a recessed cannula hub allows for unexpectedly effectivebenefits, as noted above, heretofore unexplored within the industry, letalone the intraosseous device industry.

A further possible embodiment of the disclosed system is the provisionof a small profile device in folded disposition prior to utilizationwith the stylet/cannula component extended outside the drill body andcovered in such a configuration. Upon need for use, the device may thenbe, if desired, easily disengaged from the folded configuration to allowfor access of the stylet/cannula component for drilling within a subjectpatient bone with the unfolded other component being a handle with agrip, a switch (to activate and deactivate the drill assembly associatedwith the stylet/cannula), and a further configuration to properly directand apply force for the stylet/cannula to be drilled within he subjectpatient bone. Such a configuration may be provided with the ability toaccomplish such a result while using a single hand, as well, thusallowing for freedom of use of the caregiver's other hand for otherneeded actions and/or activities, particularly in an emergencysituation. The caregiver may thus complete such an intraosseous drillingaction and then either press a release button or rotate the device inrelation to the now-implanted cannula to disengage from the cannulaitself and force, through a retractable assembly, such as, in onepossible embodiment, a spring device to return the stylet within thedrill body. Additionally, the device may then, as above, cause, uponmovement of the stylet component into and within the drill body, theclosure of a door component to seal the drill body from the exteriorenvironment. In such a manner, as above, the entire procedure is passivein terms of the safety aspects thereof. The caregiver/user simply opensthe folded device, directs and drills the extended stylet/cannulacomponent within the subject patient bone, releases the cannula from thedrill body thereby causing the stylet component to retract into andwithin the drill body itself, and the automated sealing door closes atthe exact moment the stylet moves from within the confines of thecannula (implanted within the subject patient bone) and within theconfines of the drill body. Thus, again, as discussed above, such apossible embodiment provides total protection post-contact and insertionwithin a subject patient's body (and thus after contact with andpotential infection by, bodily fluids and other possible substancesassociated with internal contact, at least; such also prevents anypossible issues with contact with the subject patient's skin, as well,if necessary) through a guarantee that any contact with the stylet isprevented since each possible occurrence would only happen while withinthe confines of the cannula or the drill body. Upon disengagement fromthe cannula as it has been implanted, the stylet automatically retractswithin the drill body; the automatic door closing sealing the drill bodyat the exact moment of stylet entry therein creates a barrier to contactwith the used stylet, as well. In any event, such a further embodimentallows for further protections and even simpler handling and utilizationthereof if desired. Furthermore, the ability to then capture the usedstylet within the sealed drill body provides, as above, a means todispose of the entire device without any contact with an infectedportion.

As well, such a separate possible embodiment also allows for the handlecomponent to house the power generator of the overall drill motor. Witha proper revolving handle around a hinge, such a structure may allow fora simple manner of disengaging the handle after utilization therebypermitting the caregiver/user the ability to dispose of the sealed drillbody separately from the powering handle component, thus allowing forfacilitated disposal overall. Also, with the sealed drill body, such maybe provided without any means to reopen such a component withoutdamaging the entirety thereof, thus preventing any subsequentutilization thereof, or even attempts at utilization, therebyguaranteeing mistaken activities with such a used stylet in the future.Likewise, the handle may also be configured to disengage automaticallyupon cannula disengagement from the drill body, as well, againpreventing any further attempts at utilizing a “spent” and possiblyinfected device.

To facilitate disposability of the overall device, as alluded to above,a separable handle and barrel are provided in one potential embodiment.In this way, the barrel would include the motor/stylet component with atleast a partial cover to prevent any stylet point contact external thebarrel after retraction. The barrel thus retains the “sharps” portion ofthe drill device and thus requires proper disposal in such a situation.Full “sharps’ disposal of the entire device may be undertaken, thusallowing for barrel and handle disposed in such a manner together;however, such a possibility may be problematic as the weight of thedevice, as well as the volume thereof, may be too great for efficient“sharps” container placement for such a purpose. Thus, again, as notedabove, the handle may be disengaged from the barrel to permit barrel“sharps” container placement and the handle disposed of in a differentmanner. A connecting hub component may be introduced within alignedcircular openings of both the barrel and the handle to permit not onlythe rotational capability (for efficient storage and transport, as wellas easy unfolding for full access as needed for intraosseous drilling),but also a connection peg that can be removed to allow for thedisengagement of all three components simultaneously, while stillproviding a stable and resilient means for rotational movement of thebarrel in relation to the handle (or vice-versa). With such a potentialembodiment of a connecting hub in place, then, the handle and barrel maybe easily disengaged for disposal purposes (as well as the connectinghub itself). The handle (and the connecting hub) may then be disposed ofas needed, whether within a standard refuse container or bag (or othertype of implement) or within a biohazard container, particularly ifblood or other bodily fluid contacts such a handle during or afterutilization. In any event, the ability to provide such a versatiledisposal capability, particularly as it concerns the need for separatedisposal activities for the barrel and handle themselves (with thefurther understanding that the connecting hub may be disposed of in thesame manner as the handle component, of course, as a separable piece. Asanother potential embodiment, however, the connecting hub may alsoinclude a resilient connection to the handle or barrel, if desired, soas to remain attached to either component subsequent to separation. Thisalternative would reduce the number of pieces of disposable componentsfor the user. The connecting hub may further simply be reintroducedwithin the circular opening of either barrel or handle during disposalthereof by the user, as well. The device may thus be presented withproper indicators for the user to as a reminder as to the need for suchdisposable of component parts. For instance, without any definitivelimitation intended herein, the barrel may be provided with a redcoloration as a “sharps” component, either in terms of an completecoloration or with stripes, wording such as “SHARPS” presented on thebarrel itself. Likewise, the handle may be colored an appropriate designto remind the user of the need for such a disposal (whether a differentred, yellow, green, etc., with complete colorations wording directed to“refuse” or “biohazard”, with stripes, dots, etc., basically any type ofdesign that distinguishes from the barrel and communicates thedisposable nature of the handle to the user.). The connecting hub mayalso include such an indication along the same lines for reminderpurposes, as well.

The utilization and presence of a power generating component, such as,in one potential embodiment, a battery or plurality of batteries,further necessitates a consideration of disposability separately fromthe handle and barrel (and connection hub) under certain regulatoryrequirements. For instance, such batteries (whether lithium, alkaline,nickel-cadmium, lithium ion, and the like, preferably, potentially, atleast, lithium in format for performance, cost, and disposabilitypurposes) are typically required under regulations to be recycled orotherwise disposed in specific ways once they are utilized as desired.In this instance, the utilization of batteries coupled with disposablecomponents of such an intraosseous device requires removal of suchbatteries therefrom prior to disposal on the handle. To that end, thehandle may include any number of different access portals for initialplacement (securely) of such a battery or batteries within the handle toconnect with contacts and thus wires (or other type of electricalconduits) to deliver the needed electrical charges for operation of theintraosseous automated drill on demand (as well as a light or lights ifdesired, as well). The access portal may be closed subsequent to contactand stowage of the battery or batteries, thus allowing for operation ofthe electrical drill upon unfolding and extension of themotor/stylet/cannula component as noted above. The battery or batteriescan then be removed upon retraction of the motor/stylet subsequent tocannula/needle insertion within a target patient's bone through suchaccess portal doors. Such a door may be disconnectable completely fromthe handle to permit such battery access and reconnectable thereaftersuch battery removal for a single handle component disposal actionthereafter. The battery access portal door may also be configured with aliving hings within the body of the handle to provide an integratedstructure that remains as a piece of the handle for single-structuredisposal above (like the connection hub alternative noted above). Theliving hinge may be provided within the rear portion of the handle,whether at the top, middle, or lower portion thereof, to allow foropening thereof on demand for battery removal purposes. Of potentialpreference in this situation is the utilization of two 9-volt lithiumbatteries provided within the handle (as a housing therefor) with,again, as alluded to above, proper snap connectors therein to permitsuitable and proper electrical transfer from the battery to the deviceitself through wires. Such wires may be configured with a certain amountof room within the handle housing such that the opening of a lowerportal door results in the batteries themselves to drop downward withinthe handle to permit access for such removal without any need of aseparate implement. Alternatively, such a battery set may have a fabricor plastic ribbon draped over an downward around them to allow forremoval, if needed, through grasp and pull of such a ribbon implement.In any event, the availability of certain living hinge battery removaldoors allows for such disposability purposes and further retention ofsuch a removal portal door for handle disposal thereafter as a singlecomponent.

The electrical connections within the handle include, again, the powergenerator (battery or batteries) with sufficient electrical strength toaccord the necessary torque and speed for the motor/stylet/cannulacombination to drill into and within a target patient's bone. Such apower generator may be, again, any type of battery (to allow forportability and utilization remotely) that provides such a benefit.Thus, for a particular potentially preferred embodiment, lithiumbatteries, particularly two 9-volts, may be utilized to generate thenecessary power levels for the drill (and possible light or lights).Other battery types, including alkaline 9-volt, C, D, and possibly AAsizes (with a large number present for such higher power levels) may beemployed in some circumstances, and may be utilized in consideration ofthe disposable nature of the overall device in line with the lithiumbatteries noted as preferred above (such lithium and alkaline batteriesare lower cost than other rechargeable types, in other words, andsimpler to recycle and/or dispose on demand; lithium batteries providestronger performance levels for the needed torque and rpms for thedrill, generally, and thus are, again, preferred). Thus, as alluded topreviously, at least two 9-volt lithium batteries are potentiallypreferred due to shape, size, power generating capability for a shortburst of energy with necessary torque and speed results, as well as easein disposal. In any event, with such a battery source in position andproperly connected through snap-on electrical connectors (as commonlyutilized with 9-volt battery types), the electrical system within thehandle thus leads through wires to a rotatable switch within theconnection hub area of the aligned circular openings of the barrel andhandle components. As in folded, pre-use state, the device is configuredsuch that the battery leads proceed to a connector lead at the topportion of the handle within the circular configuration of theconnection opening. The lead ends in a conductive metal structure (suchas copper) that is alignable with a curved lead stationed within thebody of the circular opening, as well. Again, however, in folded statethe curved lead remains at a distance from the end lead from thebatteries, thereby lacking any contact to provide charge therethrough.At the opposing end of the circular lead is present a barrel-stationedlead of a conductive metal structure (which may be substantially thesame in structure and size to that of the handle end lead). Such abarrel-stationed lead further connects through conductive and insulatedwires to the motor/stylet combination (at least) and to a furtherfinger-manipulated switch with, as one non-limiting example, a rubber orlike covering for external contact with the user for activation thereofon demand. The external switch thus includes a movable portion tofurther manipulate electrical leads within the barrel to contact withwires and/or leads to complete the necessary circuit to send power tothe motor/stylet for drilling purposes (once they are properly extendedin relation to the cannula for bone drilling purposes, of course). Thus,upon unfolding of the handle and barrel through rotation around theconnection hub, the curved lead rotates to initially contact the handlelead at a certain arc placement (which may be measured as a curve anglealong the arc path of the circular lead) with further rotation thereofallowing for continued contact and thus transfer of electrical chargefrom the batteries to the end lead stationed within the barrel. Uponoperation of the barrel switch by the user, then, and with full rotationand thus extension around the connection hub of the barrel and handle toa maximum curvature angle (for instance, from 90 to 120 degrees fromfolded state, more preferably roughly from 95 to 115 degrees, morepreferably roughly from 100 to 110 degrees), the user may then operatethe drill assembly as needed to deliver the stylet/cannula within thetarget patient's bone, provide, for instance, again, as a non-limitingpossibility, a quarter turn in the direction opposite the drillingactivity of the drill device including the motor/stylet combination,whereupon the motor/stylet combination retracts back within the barreland a cover automatically covers the stylet point to prevent any contacttherewith. The handle may be manipulated from folded to unfolded statewith a single one-handed motion by the user, if desired, through athrowing or like motion applied to the folded device while retainingsufficient hold on the handle itself. Such a movement thus accords thedesired rotation of the barrel around the connection hub to provide thedesired and necessary electrical connection from handle to barrel, andlock into place with a properly configured connection hub article thatprevents unwanted movement from such a fully unfolded, extended state topermit full, unfettered use of the drill with grasp of the handle andactivation of the barrel switch. The locked connection hub cansubsequently be manipulated, at least in one potentially preferredembodiment, to allow for barrel rotation back to a nearly folded state,if desired. Such a connection hub may be pressed inwardly to disengage adetent, for example, within the aligned circular openings of the barreland handle, thereby allowing for such return rotation to occur. Thecircular lead being configured along such an arc path remains as aproper and effective conduit of energy from the handle lead to thebarrel end lead along a significant length of such a curved lead path upto, for instance a 20 degree angle between handle in folded state andunfolded state. In other words, the barrel may be rotated around theconnection hub from its fully extended unfolded state to a 20 degreeangle from its original folded state (as one non-limiting example)without losing electrical connection from batteries to barrel end lead.Likewise, the connection hub and circular openings of both handle andbarrel may be properly aligned to effectuate a certain amount offriction to ensure the barrel does not simply fold downward afterconnection hub manipulation and disengagement of handle and barrel fromfully unfolded state. In this manner, actually, the barrel may berotated to any curvature angle around the connection hub from unfoldedstate to nearly fully folded state and allowed to remain at any selectedcurvature angle on demand. This is a benefit associated with thepotentially preferred embodiment of a bottom edge of the handle being ofa flat nature and of sufficient width to actually stand erect on a flatsurface without toppling over.

Such a bottom edge structural configuration of the handle permits acouple of beneficial characteristics, then, without such an embodimentof the overall device. For example, the bottom edge of the handle mayitself include an extension that protrudes forward of the handle base asit is unfolded and that simultaneously provides an initial cover for thebarrel aperture prior to use and in folded state. Thus, the protectivenature of such an extended bottom handle edge of the barrel opening, letalone the motor/stylet/cannula combination prior to extension out of thebarrel aperture provides, as well, a sturdy base for placement of theunfolded device prior to, during, and after utilization for bonedrilling, as well as a base for the device with the barrel rotated asnoted above to an angle that permits directional pointing, for instance,of the barrel from fully extended unfolded state to near folded state,while standing on its own on a substantially flat surface. Such arotational capability may help the user in keeping track of such adevice during an emergency situation, as well as allow for a furtherembodiment of the overall device that has heretofore been nonexistentwithin the intraosseous device industry.

The utilization of a proper light or an array of lights, as merelyexamples, in conjunction with an intraosseous device has been lacking,particularly in terms of providing a sufficient amount of candle powerfor utilization of any such light integrated within the device itself toaid a user in viewing a specific drilling location without having toutilize a different light source (such as a flash light) with anotherhand. The ability to utilize a single-hand approach and allow for theother hand freedom for other emergency activities for a target patientis significant in this situation, particularly as the device may beneeded within an emergency situation that is dark or poorly lit and thusrequires appropriate visibility for such an undertaking, particularlydrilling within a target patient's bone. The inclusion, thus, of a lightor light array within and/or around a barrel aperture of the disclosedintraosseous device is of great value and heretofore unexplored withinthis specific industry. Any type of light, such as, without limitation,a LED, optical fiber, and the like, that does not require a significantamount of power for functioning yet supplies a sufficient candle power(at least 10 candelas, for instance) to act as a light source fordirectional aid in relation to the motor/stylet/cannula placement andoperation on a target patient (and thus to allow for full visibility ina dark or poorly lit environment, for instance, of the target bonedrilling site). A single LED, or like, light source may be provided atthe lowest point of the barrel, as one non-limiting example, that shineforward in the same direction as the stylet/cannula during a drillingoperation. Alternatively, an array of lights (from 2-8, for instance,more may be present as well, of course) may be provided to increase thedegree of visibility for the user, as well and situated, for example,around the barrel opening periphery. At least one wire may thus beattached from the barrel end lead, or even the curved rotating lead, tothe light source directly. In this manner, then, the light source mayactivate the moment the rotation of the curved lead reaches the properangle for the power source from the batteries to conduct through thehandle lead to the barrel portion (whether the curved lead or barrel endlead). Thus, the light or lights may automatically activate upon suchunfolding of the handle and barrel with the light(s) serving as asuitable indicator that electrical charge is present from the battery tothe barrel end lead for drill motor operation as well. Such an initialindication is thus a further benefit of the lighted alternative.Furthermore, however, is the ability subsequent to drilling operation,and thus retraction of the motor/stylet within he barrel andimplementation of the cannula needle within the target patient's bone tothen utilize the drill device itself as a flashlight on demand ifdesired. The further ability of the device to stand alone, as notedabove, and the barrel to rotate on demand around the connection hub andremain in place at any angle further allows the user to then place thedevice on a suitable surface and have the light source direct as desiredat a direction from the full unfolded state angle to as low as about 20degrees from folded state while still retaining the necessary electricalconductivity between batteries and light source to provide a versatle,self-standing flashlight in addition to a drill device. Again, such abeneficial device has never been provided within the intraosseous deviceindustry.

As another possible embodiment encompassed herein, there is anintraosseous device comprising a disposable drill/stylet combination,wherein said drill includes a stylet retraction port therein, aretracting mechanism attached to said stylet and disposed within saiddrill, and a cannula connected in detachable relation to said stylet,wherein said stylet is permanently attached to said drill, wherein saidretracting mechanism operates subsequent to utilization of said drill tointroduce said stylet and cannula within the intermedullary space of asubject bone, said retracting mechanism moving said stylet from anexternal location to said stylet retraction port within said drillsubsequent to a drilling operation, and wherein said cannula is attachedto said drill with a Luer lock component with a lip portion presentexternal to said drill and an automatic closure internally within saiddrill that activates upon disengagement of said cannula from said drill.The external lip of the cannula also provides, if needed, a surface fora user to grab while maneuvering the drill. Also encompassed herein isthe inclusion of a sensor on said stylet, wherein said sensor measurespressure subsequent to bone entry such that once passed through to saidintermedullary space the pressure difference deactivates the drill andactivates the retraction mechanism and detaching from said cannula. Themethod of utilization of such a device (with or without the sensor asdescribed) is also encompassed herein wherein the cannula as retainedwithin the bone and skin and accessing said intermedullary space of thesubject bone allows for introduction or removal of fluid, etc., therein.

As it potentially concerns the utilization of the retracting stylet, theability to provide a passive safety regimen may be accomplished in anumber of ways. As noted herein, an automated door, whether internal orexternal to a barrel portion of the overall device may be utilized,closing through any number of possible means subsequent to styletretraction. Such means may be pressure-based, such as remaining open asa stylet component is extended for drilling purposes (and associatedwith a cannula, as noted above) through a spring, or other likecomponent, and shutting as the stylet (on sled, associated with a drillmotor, or both, as examples) retracts back into the barrel itself oncedisengaged from the cannula. Such a door would provide a potentiallycomplete cover, but, more importantly, prevents the ability of a user toaccess the sharp end utilized to drill/penetrate a patient's body (andsubject bone). In such a way, then, the automatic retraction of thestylet causes the immediate closure of such a door for such protectivepurposes. Alternatively, however, and potentially preferred, is theability to provide a cover guide, rather than an entire door, thatprovides a distinct needle access obstacle in much the same way as notedfor a door above. In other words, if needed for sharp stylet endcoverage effectiveness, and/or for proper internal configurationpurposes of a retracted stylet puncture end cover, particularly if thebarrel shape may not be particularly conducive to an automated internaldoor structure itself, a rotating arm mechanism may be utilized instead.Such an arm may, again, be forced away from the barrel opening and keptto the side while drilling is undertaken and then rotate to its desiredposition covering substantially the middle of the barrel just above theactual stylet sharp end (and, again, potentially infected needle end) inorder to prevent a user from accidentally (or purposely, for thatmatter) contacting such a sharp needle end upon operation of suchautomated arm movement. In either way, whether a door or an arm (and, ofcourse, such an arm may be considered a partial cover of any size andshape that properly resides and moves as needed within the confines ofthe device barrel, particularly at the egress point, of course, and thuscould be a small disk, a square shape, a curved arm, basically anygeometric shape structure provided in such a manner), the automatedmovement thereof in relation to the retracted needle/stylet provides thepassive safety protection heretofore not available within the industry.Additionally, then, if an arm, or other type of partial, thougheffective, cover protects the user from puncture/infection afterutilization and stylet retraction, there may be a need to providefurther protections to ensure any fluids on the used stylet needle donot exit through the barrel and in contact with the user (or anyoneelse). The door possibility provides a reliable means for such apurpose, of course, particularly if it closes (and possibly seals) insuch an automatic fashion. The rotating arm may have a certain amount ofroom that is not covered, though, leaving, potentially, the possibilityof bodily fluids, etc., exiting the stylet and thus the partially closedbarrel. To possibly combat such a occurrence, the movable sled componentmay include a stowed protective film that covers the top portionunderneath the arm that unfolds and creates a fluid barrier upon suchsled retraction.

In another possible embodiment of the disclosed intraosseous device, asalluded to above, the drilling motor and stylet are integrated togetheras a permanent component of the overall system. In this potentialembodiment, however, the motor may be provided as a direct drive type(without the need of a gear box, for instance) that generates a desireddrilling effect (spinning) that transfers such energy to an extended andintegrated drill bit, herein a stylet. In this manner, the ability tomanipulate the motor and stylet together, both to extend from the devicebarrel for drilling purposes and to retract within the barrel subsequentto utilization, effectively creates a single component that temporarilyconnects with a cannula (needle) in order to introduce both stylet andcannula within a target bone, but the motor and stylet retract togetherleaving the cannula therein. Such a retractable component, again, asnoted above, allows for the user never to handle or contact the stylet(whether the shaft or the pointed end) at any time subsequent todrilling, thus avoiding any potential unsafe touching with a stylethaving bodily fluids, etc., thereon. The direct drive motor is ofsufficiently small profile to fit within the confines of the barrelhousing and generate sufficient power for proper drilling by thestylet/cannula within a target patient's bone (and through skin, etc.,as well), all within a time frame of at most roughly 5 seconds,preferably 3, most preferably at most 2. The torque applied for such apurpose may be measured in any manner as long as the time frame is metand the introduction within the target bone is accomplished. Such ameasure is from about 0.9 to 1.1 Nm, more preferably about 0.95-1.05 Nm,and most preferably about 0.98 Nm. As such, a rotational rate ofanywhere from 500-1750 rpm (more preferably from 1000-1500 rpm, mostpreferably about 1500 rpm) may be undertaken. In other words, the motoritself produces enough torque to meet the base requirements as notedabove in terms of time and bone introduction. The battery power providedfor such a purpose may be met through the utilization of any type ofstandard cell, with, as noted above, lithium 9-volt types (two forexample) as providing sufficient levels for such drilling activities, aswell as allowing for lower costs and facilitating disposal thereof asneeded subsequent to utilization. The required voltage for the motorfunctionality is roughly 10-15, more preferably around 12. The stallcurrent for the motor is provided in amps, roughly from about 2.5 to 5,more preferably from about 3 to 4, with about 3.2 most preferable.Furthermore, as noted previously, to provide a suitable low lengthbarrel, and to allow for retraction of a used stylet subsequent todrilling, the motor/stylet/cannula are present on a movable internalsled component. Such a sled may be manually maneuvered to allow forextension of the stylet/cannula from the barrel opening for accessthereof to a patient. Such maneuvering may be provided through, in onepossible embodiment, juxtaposed grips external and on the sides of thebarrel housing that protrude therefrom for the user to push bothsimultaneously. An internal spring surrounding the motor/styletcomponent compresses as the external grips are forced toward the barrelopening in this manner, thus sliding the sled (with such a “sled”potentially being the motor/stylet component on its own without the needfor an undercarriage for such a purpose in this embodiment) a certaindistance to allow for stylet/cannula extension outwardly while the motorportion is retained, at least in part, within the barrel itself. Thespring thus compresses and the sled locks into place with thestylet/cannula extended in this manner and awaits further action in theway of the stylet and cannula disengagement subsequent to drillingcompletion. Such disengagement may be accorded in any manner, butpreferably utilizes a simple quarter (or similar degree) turn of thedevice (and thus motor/stylet component) in the direction opposite thedrilling rotation. The stylet (as integrated within the motor, ofcourse) includes at a base location thereon extended arms that interfacewith the recessed hub (in one potentially preferred embodiment) openingsof the cannula and as the drilling rotation proceeds such arms move thecannula in tandem to allow for the complete insertion of stylet/cannulawithin the target patient's bone. The quarter (or like) turn in theopposite direction thus allows for the stylet arms to move to parts ofthe cannula hub recesses that simultaneously lose contact, thus allowingthe stylet (and thus motor) to disengage therefrom and, with thecompresses spring in place seeking to extend back to its originaluncompressed state, the release between stylet and cannula effectuatesthe automatic retraction of the sled back within the barrel housing,leaving the cannula within the target patient's bone. The spring thusmay actually “lock” into place upon compression as the cannula portionextends outside the barrel opening with the device release rotationcausing such disengagement and spring release as needed at the openingas well as at the stylet/cannula interface. Also, if desired, theinternal spring may be outfitted with a protective film or like materialthat manipulates easily as it is compressed and extended in order toprotect the internal components within the barrel housing from moistureand other elements, at least. Since the external grips (which may alsobe provided on top and bottom opposing sites of the barrel housing, oreven at 90 or so degree angles from one another on different sides ofthe housing, as well; furthermore, even a single maneuvering grip may beprovided alone for such a purpose, if desired) must be external thebarrel housing in order to maneuver an external sled (or, again, themotor/stylet/cannula without an actual base present), there may beingress points for moisture, etc. Thus, a film may cover such an openingor at least the spring itself, if desired. In any event, the ability togenerate such retraction is paramount to providing the necessary passivesafety benefits disclosed herein for the overall device. Additionally,then, and again as discussed above, the barrel housing may include anautomatic closure or at least cover over the stylet point uponretraction thereof to further add to the safety aspects providedpassively thereby.

Additionally, if desired, and as another potentially preferredembodiment of the disclosed intraosseous device is the inclusion of aninternal cap structure to surround the motor/stylet as well as aportion, at least, of the internal spring during storage and initialextension prior to utilization thereof. Such an internal cap may accordsome protections, as well, along the openings associated with themaneuver grips (handles) to extend the motor/stylet/cannula prior touse, as well. The internal cap also preferably exhibits an extension endthat includes an opening that is narrower than the barrel opening, butsufficient wide to allow for the cannula hub to extend therefrom priorto and during use, at least. Such an extender cap thus provides asuitable location for the user to actually place his or her fingers fordirectional purposes when the drill is contacting and drilling into atarget patient as well as to grip the cannula hub subsequent to drillingin order to best ensure the device can be turned in the oppositedirection to retract the motor/stylet within the barrel housing, asnoted above (and thus for the spring to extend, as well). In such amanner, then, it may be preferable for the internal cap to retain itsposition extended partially from the barrel housing. Such movement andretained extended position of such an internal cap would be permittedthrough the inclusion of a tab at the top (or another location, ifdesired) and rear portion of the internal cap itself, ostensibly actingas a buttress to retraction when moved forward with the motor/stylet.Two spaced complementarily shaped openings on the top of the barrelhousing would thus provide egress points at the non-extended locationand then the extended location for the internal cap with the lattercreating a catch to prevent retraction of the internal cap itself afterrelease of the motor/stylet from the cannula hub. The tab in theinternal cap thus extends outwardly from the cap with an angledstructure that has a slope that allows for movement forward along theinternal part of the barrel housing, but with a flat end that catches,again, within the opening near the barrel housing opening. Such barreltop openings may actually be provided as indicators themselves as to thestatus of the usability of the overall device as the rear top openingmay be outlined, for example, in green (to indicate a ready-to-usestatus) while the opening nearer the barrel housing opening may beoutlined in red (to indicate it no longer can be used), thus allowingfor further benefits as to status communications to the user. Such acatch for the internal cap also provides another benefit in that theextended cap protrusion (that aided in allowing for the user to graspthe same during and after drilling) extends a sufficient distance thatthe user cannot then completely fold the handle back to its originalposition over the barrel opening. In this way, there would be no way theuser would mistakenly think the disposable device may be used again as adrill (although, as noted above, in at least one embodiment, it maystill be utilized as a flash light, potentially). Thus, furthercommunication as to device status is supplied in this manner.

In any event, the disclosure herein is directed to the complete passivesafety capability of an intraosseous device and the method of such aresult utilizing such a device. The stylet component, again needed tobest ensure proper drilling through such a bone and prevention ofdeposition of bone fragments and other body materials within the cannula(for effective utilization thereof to introduce and/or remove materialstherethrough to and/or from the target bone). Thus, although retractionthereof would be potentially preferred, particularly for the mostreliable and effective passive safety regimen with such an intraosseousdevice, such a stylet component may actually be provided as a removablecomponent from the internal structures of the drilling device itself.Thus, if desired, the stylet may be detachable, and thus not permanentlyattached, to the drilling components and still be considered within thescope of this disclosure. Thus, as a non-limiting example, the styletmay be screwed or otherwise connected within an internal rotatable basestructure and not permanently integrated or attached thereto, and stillbe within the scope of this invention. In other words, mere provision ofa detachable stylet would not accord any distinction from the disclosedstructures and inventive features of this passive safety intraosseousdevice.

Additionally, the ability to provide a stationed, as opposed tosled-based, motor and gearbox combination within the drill deviceitself, would also allow for a configuration wherein the drill handlemay actually be provided within the middle of the underside of the drillhousing, rather than at the near end. In this manner, the user wouldhave greater control of the drill itself with the trigger control (whichmay include two structures or one in series, related to initiallyextending the internal base with the stylet/cannula combination andopening the first door/seal for such egress, as well as priming thesecond closing door/seal as well as activate the drill operationsthereafter such extension) in place within such a mid-placed handle.Such a handle may also be provided as a swiveling or other likeimplement that stows in such a manner to provide a smaller and thinnersize when not in use. Such a configuration may allow for more efficientpackaging and shipping, with the added benefit of housing, as anexample, a power supply situated therein (such as one or more lithiumbatteries, preferably). In this manner, the swiveling (or other design)handle component may be provided with a power connection within its topportion that contacts, upon placement in full extension, with acomplementary connection within the drill housing. Thus, when stowed,the power supply will not have any way to initiate any power usage untilactivated physically by the user, thus providing a more reliable resultupon utilization.

Furthermore, with such a device, and due to the common actions andexpectancies of users that undertake detachment activities of rotatingimplements, the actual rotation alignment of the stylet/cannulacombination may be provided in counter-clockwise fashion, rather thanclockwise, if desired. In this way, the user may employ the drill asneeded, and in a direction as above, and then the rotation to detach thecannula, at least, may be clockwise, rather than counter-clockwise, tomake it potentially easier for the user. Of course, the typicalclockwise drilling and counter-clockwise detachment may also beutilized.

The disclosure thus provides a novel intraosseous device that exhibitscomplete passive safety in order to prevent any possible contact withthe used stylet by a user (and such a result is achieved without anyaction by the user to actively maneuver any parts that would be externalto the drill and cannula during such an activity). Such accords the userwith, as well, the potential for a completely disposable drill/styletcombination for a single use purpose of both. In such a manner, thedrill is provided not only with a power supply that is focused on such asingle use directive, but also provided, if desired, with a shape thatallows the user the ability to manually screw the drill component (suchas if the power supply somehow proves ineffective at the moment ofactual use). The permanent connection with the stylet, with theautomatic closure to prevent stylet exposure upon disengagement with thecannula, allows for complete passive safety and, if desired, disposal asa single unit of the drill/stylet combination, thus according the user,particularly in an emergency instance, the ability to completely andsafely handle the overall device post-drilling and cannula retention.The ability to avoid any need to handle the loose stylet after drilling,and the prevention, automatically, upon such drill disengagement withthe cannula of any exposure to such a contaminated stylet, provides sucha basis and benefit. As well, the single drill/stylet combination indisposable form allows for the user to know in each instance that s/hewill have the entire device at hand at that moment when it is needed.There is no need to keep a separate drill with a box of differentlysized stylet/cannula implements; to the contrary, with this inventivedevice, the user has, as one possible example, an entire hermeticallysealed drill/stylet and cannula device ready for utilization, and thusneed only to then operate the drill with the stylet and cannula inplace, introduce the stylet and cannula within a subject patient's boneand into the subject bone's intermedullary space, discontinue thedrilling, decouple the retraction mechanism automatically to detach thestylet from the cannula and deliver the stylet into the drill and withinthe retracted stylet port. Thus, with this inventive device, the userhas an all-in-one device that leaves a bone-retained cannula forutilization as a port therein for fluid delivery and/or removal and aseparate, integrated drill/stylet combination that, with the sharpstylet retracted within the drill body and automatically and completelyenclosed from any external exposure as well, can then be placed as asingle implement within a sharps (and the like) disposal bag (or likecontainer) without any fear of puncture from the now-contaminatedstylet. Such a device and system has not been employed let alonedisclosed within the medical industry.

Additionally, then the inventive device may include a sensor at thestylet tip (or at least adjacent thereto), or as described above, themotor itself, that activates upon pressure application at the skinand/or bone of the subject patient. Once such is introduced in thismanner, the sensor increases in pressure detection once the styletcontacts the bone itself. Thus, once the stylet enters the subject boneintermedullary space, the pressure drastically reduces, indicating thepresence of the stylet within such a space. Once this pressuredifference is measured, the sensor indicates the same to the drill motorand stops the power from running at that instant. Such a pressure sensorthus accords the user the ability to control the depth of thestylet/cannula entry, effectively preventing the stylet from enteringthe bone too far and, for the most part, allowing for maximal access tothe intermedullary space of the subject bone for introduction/extractionof fluids, etc., through the retained cannula. Furthermore, then, thesensor deactivation of the drill may further lead to activation of theretraction mechanism of the stylet to decouple from the cannula (thusleaving the cannula, again, retained within the patient's skin and bonefor further utilization) and then retract up into the drill within arecessed port therein for safe handling thereafter. Certainly, the sharpend of such a stylet is to be avoided both prior to and after actualutilization as an intraosseous implement. The ability, particularly whenin an emergency situation, to merely handle a device with an exposedstylet prior to drilling, and not afterwards (when contact with thesubject patient's fluids, etc., heightens the potential problem withpiercing/puncturing one's self as a paramedic, clinician, EMS personnel,etc.) is of enormous importance, certainly. Such a retraction mechanismthus may be employed as the drill stopping and then turning the otherdirection until the stylet is delivered to the retraction port. Thedrill, as noted above, also includes an enclosure that automaticallycloses upon disengagement from the cannula or upon retraction of thestylet. If desired, however, the drill may also or alternatively includean enclosure that automatically maneuvers in place over the styletegress opening upon movement of the stylet implement into the retractionport (such as a spring-loaded sliding mechanism that activates once theentirety of the stylet passes through such an opening). In this manner,also, the coupling of the stylet to the cannula may be provided with anabutment as the drill activates in the “forward” (towards the bone)direction, thereby causing the cannula to move with the stylet. In theopposite direction however, the abutment may release as the styletrotates in the opposite direction allowing for the decoupling of the twocomponents as needed. Certainly, any other type of coupling anddecoupling mechanism may be employed for such a purpose and theretracting mechanism may be of any other type as well. For instance, aspring-loaded component may work with the drill to push the stylet“forward” when the drill is activated and then, upon disengagement ofthe drill, the spring releases as well forcing the stylet up into thedrill chamber of placement within the retraction port. In such apossible alternative, then, the coupling with the cannula may be thesame type of abutment configuration but with the discontinuation of thedrill according the spring-loaded implement therein to not only move thestylet upward into the drill chamber, but also when the alignment allowsfor decoupling with the cannula, the full movement is further permittedand operated.

Alternatively, then, the potential presence of a sensor may be employedon the motor and/or gearbox as well or instead. In this manner, theinitial torque of the drill, prior to skin and bone contact, will bemonitored and upon penetration through the target bone, such a readingwill again be attained thus indicating and allowing for immediatedeactivation of the motor and/or gearbox (and effectively stopping thedrill). Thus, because the torque measurements (and pressure, for thatmatter) will increase as the rotating stylet/cannula combination pastthrough the target bone, once such is completed and the intermedullaryspace has been reached, the pressure measurements will changesignificantly enough to provide such deactivation indications and/orcontrols automatically. In other words, the specific gear required toeffectuate such a drilling operation will initiate at a starting level,move to another higher gear thereafter to increase the torque applied,and, upon penetrating through a target bone, the gear may then changeback to a lower one. At that point, such a sensor may then activate toturn off the drill motor.

Another potential embodiment of the overall intraosseous device utilizesan internal spring-loaded component housing the stylet, a gearbox, and amotor (such as on a sled-type implement). Such a spring-loaded componentthus rests in non-compressed (fully protracted) state with the styletpresent within the body of the drill housing itself (as well as thegearbox and motor which are connected thereto). Upon decision to utilizethe device, the user would compress the spring through an externalhandle (with a separate handle utilized as a post for such a compressionforce to take effect), thereby pushing the overall sled-type componentoutward to an egress opening within the drill. At such an opening wouldbe the cannula with a Luer lock attachment with a screw-type portionconnected to the drill at such an egress opening and a lip portionexternal thereto. The cannula includes a lumen that is permanentlyattached to the Luer lock implement, as well, and aligned such that thespring-loaded component forces the permanently attached stylettherethrough the bore of the hollow cannula and extending to provide thestylet tapered end through the end thereof. At such a point, the springallows for the sled-type implement to move linearly to such a stop andthen latches a catch point within the drill that prevents any furthermovement to decompression state. Once this latch is in place, the motoris then aligned with a power source, or alternatively, a switch isproperly closed to allow for the motor to then be activated. Withactivation, the stylet then drills as a drill bit-like implement withthe user then pushing forward on the drill device itself to force thestyle and cannula through the target patient's skin and target boneuntil reaching a desired depth (whether alerted by sensor or not). Oncethis action is over, the user can then, as one example, turn the drill aquarter, half, third, etc., any degree rotation to unlatch the sled-typeimplement from the cannula allowing it to then retract in to thenon-compressed spring status. Of course, any manner of unlatching may beundertaken as long as the retraction occurs while the cannula is stillattached to the drill. Such effectively moves the gearbox, motor, andmost importantly, used stylet back within the confines of the drillhousing. Thereafter, the user then detaches the cannula from the drillend; such may be accomplished with a turning action, as noted above,subsequent to and to a larger degree than for the retraction operation.Once this occurs, and the screw-type portion of the cannula Luer lock isfree from the drill, a pressure-based closure (in contact with thecannula when in place), then automatically and immediately covers theegress opening of the drill. Such a pressure-based closure may beprovided on one side of the Luer lock and thus close instantaneously inthat one direction once the Luer lock (or portion thereof) and thepressure-based closure are no longer in contact with one another.Alternatively, there may be two opposing pressure-based closures thatmeet half way across the drill housing egress opening upon disengagementof the Luer lock. As another possible alternative, the drill may includea pressure-based or other type of automated closure that is furtherwithin the drill housing as to cover an enclosure tube housing thestylet prior to extension and after retraction back into the drill. Inother words, such a tube may provide a directional cover or at least asimple enclosure for the extendible and retractable stylet. External tosuch a tube, which itself would include an egress opening to permit suchextension of the stylet into and through the cannula when in use, butwithin the confines of the drill housing, may thus be a pressure-basedclosure, much like that discussed for the Luer lock cannula egressopening. However, in this situation, the pressure-based cover would notbe primed for spring (or the like) decompression until the styletretracts back into such a tube and/or the movable platform including thestylet, gearbox, and motor, at least, moves back into its originaldecompressed state. In this manner, either the stylet tube coverpressure-based closure may be provided, in one possible embodiment, insuch a primed position separate from the location of the platform, or itmay be actually aligned and attuned to the platform movement. Thus, itis not aligned (and thus separate) from the platform movement and/orlocation, the closure may be activated by a mechanical device thatreleases the spring thereof only upon retraction of the stylet and/orentire platform. If aligned with the platform and/or stylet, then such apressure-based closure may be maneuvered itself into place over the tubeegress opening when the stylet is extended into and through the cannulacore and then activate at its own static location to close upon suchstylet and/or platform retraction. In either case, this alternativeprovides, again, a definitive passive safety implement and procedure forintraosseous activity due to the automatic retraction of the stylet andthen automatic enclosure thereof upon such movement. If desired, aswell, the retraction mechanism may be related directly to the motoractivation which may be programmed or at least controlled by theattainment of a proper depth of stylet and thus cannula insertion withina target bone. In such a manner, then, the motor may be associated witha sensor or simply by the completion of the necessary drilling action(drill no longer moves forward, for example, while drilling), or thepower supply ends after the necessary amount has provided the drillingresult desired. In either case, the combination of such automatic turnoff and automatic retraction thereafter (will the potential forautomatic closure of the stylet housing tube) provides a total automatedpassive safety result heretofore unexplored within this medical area.Such a result, whether utilizing the Luer lock “controlled” closuredevice or the stylet retraction “controlled” closure device, the abilityto provide total protection from used stylet contamination, particularlyin terms of the automatic closure of the only access opening (oropenings) to such a retracted used stylet provides such a passive safetybenefit and method wherein the stylet has no possible externalcontamination itself outside the cannula and/or drill housing subsequentto drilling.

With such in mind, then, the ability to retract the styletautomatically, seal it off automatically, and provide any furtherautomatic protections simply through the disengagement of the drill fromthe cannula (thus providing the necessary access for drug delivery,matter removal, or other end use, including, without limitation, stemcell collection) is of great importance to provide the necessary passivesafety results. As such, although it may be preferable to have a fullyintegrated stylet (as it is connected with the gearbox, motor, and/orany other component within the drill), such may actually be avoided toprovide, for example, and without limitation, the ability to provide arecyclable drill, albeit with, for example, a module including theretracted stylet, with or without any other inner component, that iscompletely disposable, is also a possible embodiment of this disclosure.In other words, the ability to retract the stylet automatically is theimportant consideration; the fully integration thereof within the drillis a possible embodiment, but not required in every instance due to thepotential to jettison the retracted (and safely enclosed) stylet afteruse. Of course, being held in such an enclosed state within the confinesof the drill housing allows for full disposability of the entire device,if desired, as well.

In terms of disposability, then, the device may be configured andsupplied to allow for a single use thereof, again, if desired. In fact,the device may be provided within a single hermetically sealed (andpre-decontaminated or like treated state in total, ostensibly for safetyfor the target patient, of course) package (such as a polyolefin, likepolyethylene, polypropylene, polybutylene, or other polyolefin, or blendthereof, a polyester, a nylon, a polyacrylate, a polylactic acid, etc.,and combinations thereof) that may easily be opened by a user, kept byhis or her side during utilization, and then used as a final disposable(or returnable) package to hold the used drill device. In such a manner,then, the user may utilize the separable connection means (such as aperforated line, a tearable zip-lock, and the like) to access the drilldevice in total, use it until the cannula remains in the bone for activedelivery or material removal therefrom, as needed, and then take thesafe, stylet retracted and sealed device and place it back within thepackaging with a different sealing implement provided to prevent anyother possible contamination thereof. Such could then be totallydestroyed, if desired, or the mechanical portions thereof may bereclaimed and recycled for inclusion within another new drill devicewith full decontamination of any components thereof as originally used.Such a stylet, however, will never be utilized again and the tube withinsuch an implement is thereafter kept after retraction may be a modularcomponent that allows for utilization of the other structures andcomponents that did not involve direct contact with the target patient'sskin, fluids, and bone.

To provide a compact structure, initially, as stored and transportedbefore utilization, such a device may include, as alluded to above, afoldable handle portion. In such a manner, the handle of the drilldevice may actually stow to avoid a bulky end portion thereof. Thisfolding handle may also include a power source (batteries, for instance)that remain unaligned with the electrical parts of the drill until movedto the desired position. Such a handle may thus also be provided asdetachable from the drill, to allow for facilitation of possiblerecycling thereof. Decontamination and disinfection (as needed) may thusbe undertaken with the detached power supply/handle component to allowfor acceptable further utilization in a different and later activity.The foldable handle may thus fold either forward on the bottom rearportion of the drill or backward thereon.

The overall drill may, in this type of embodiment, include two or moresled-type implements if desired in order to more efficiently (andpossibly reduce size overall of the device) accomplish such a passivesafety result. Additionally, the drill may have a handle that folds formore improved storage purposes and may include a battery (or multiplebatteries) therein as well. The cannula may be provided with screw-typechannels at the insertion end, as well, to potentially improve retentionwith a target bone as well as facilitate drilling therein. Additionally,the drill may solely rotate the stylet component for such an action or,alternatively, may engage with the cannula to rotate simultaneously withthe stylet.

These and other aspects of the disclosed subject matter, as well asadditional novel features, will be apparent from the descriptionprovided herein. The intent of this summary is not to be a comprehensivedescription of the subject matter, but rather to provide a shortoverview of some of the subject matter's functionality. Other systems,methods, features and advantages here provided will become apparent toone with skill in the art upon examination of the accompanying FIGURESand detailed description. It is intended that all such additionalsystems, methods, features and advantages that are included within thisdescription, be within the scope of any claims filed now and/or later.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features believed characteristic of the disclosed subjectmatter will be set forth in any claims that are filed now and/or later.The disclosed subject matter itself, however, as well as a preferredmode of use, further objectives, and advantages thereof, will best beunderstood by reference to the following detailed description of anillustrative embodiment when read in conjunction with the accompanyingdrawings, wherein:

FIG. 1 depicts a cross-sectional view of one possible embodiment of adrill device described herein prior to utilization in an intraosseousprocedure.

FIG. 2 depicts the same device as in FIG. 1 with the stylet insertedthrough the cannula for drilling operations.

FIG. 3 depicts the same device as in FIG. 2 subsequent to drilling withthe stylet retracted.

FIG. 4 depicts the same device as in FIG. 3 subsequent to cannuladetachment.

FIG. 5 shows a cross-sectional view of a drill device having anextendible internal base alternative embodiment in pre-extended form andwith a mid-portion handle in stowed position as packaged.

FIG. 6 shows the device in FIG. 5 with an unstowed handle.

FIG. 7 shows the device in FIG. 6 with opened initial door at the drilldevice distal end.

FIG. 8 shows the device in FIG. 7 with the internal base assemblyextended and the stylet/cannula combination provided with portionsexternal the egress point of the distal end.

FIG. 9 shows the internal assembly of FIGS. 5, 6, 7, and 8 in greaterdetail.

FIG. 10 shows the device in FIG. 8 with the cannula in place within apatient's target bone and skin, the internal assembly with the styletretracted within the device, and the drill device second door closed toprotect from the retracted stylet automatically.

FIG. 11 shows a side view of the close-up of the stylet/cannulacombination of FIGS. 5, 6, 7, and 8.

FIGS. 12, 13, and 14 show different close-up views of the interfacebetween the internal assembly rotatable arms and the cannula base withthe capability of temporarily connecting therebetween and the ability ofdetaching through a slight turn and pull away of the internal assembly.

FIG. 15 shows a side perspective view of another potentially preferredembodiment of a stowed and folded handheld passive safety intraosseousdevice of the disclosure.

FIG. 16 shows the deployed and ready to use device of FIG. 15.

FIG. 17 shows a side view of the same device of FIG. 15.

FIG. 18 shows a side view of the same device of FIG. 16.

FIGS. 19 and 19A show a cross-sectional view (19 side perspective and19A side view) of the device of FIG. 15.

FIG. 20 shows a side, bottom cross-sectional view of the device of FIG.16 after the stylet has been retracted within the drill body.

FIG. 20A shows a side perspective cross-sectional view as in FIG. 20.

FIG. 20B shows a close-up side perspective view of the sealed drill bodyafter cannula disengagement.

FIG. 21 shows a side cross-sectional view of the stylet and cannula withstylet motor shaft permanent connection.

FIG. 21A shows the disengaged stylet and cannula of FIG. 21.

FIG. 21B shows a rear side perspective view of the stylet and cannulaconnection as in FIG. 21.

FIG. 22 is a side perspective view of the device of FIG. 15 post-use andupon separation of sealed drill body and handle.

FIG. 23 is a side perspective view of another potential embodiment ofthe disclosed device in closed, pre-used position.

FIG. 24 is a side perspective view of the device of FIG. 23 in unfolded,pre-used position.

FIG. 25 is a side perspective view of the device of FIG. 24 in primed,extended position ready for intraosseous drilling utilization.

FIG. 26 is a side view of another potential embodiment of the discloseddevice in closed, pre-used position.

FIG. 27 is a side view of the device of FIG. 26 in unfolded, pre-usedposition.

FIG. 28 is a side perspective view of the device of FIG. 26 in primed,extended position ready for intraosseous drilling utilization.

FIG. 29 is a cross-sectional side perspective view of the FIG. 24 devicein unfolded, pre-used position.

FIG. 29A is a cross-sectional side view of the FIG. 27 device inunfolded, pre-used position.

FIG. 30 is a cross-sectional side perspective view of the FIG. 25 devicein primed, extended position ready for intraosseous drillingutilization.

FIG. 30A is a cross-sectional side view of the FIG. 27 device in primed,extended position ready for intraosseous drilling utilization.

FIG. 31 is a cross-sectional side view of a potential embodiment of thedisclosed device subsequent to stylet retraction after drillingutilization.

FIG. 31A is a top side cross-sectional perspective view of a potentialembodiment of the disclosed device subsequent to stylet retraction afterdrilling utilization.

FIG. 31B is a close-up top side perspective view of the drill opening ofthe device of FIG. 31A subsequent to stylet retraction and needledisengagement.

FIG. 32 is a side perspective exploded view of a potential embodiment ofa stylet/needle combination for utilization with the disclosed device.

FIG. 32A is a cross-sectional side view of the stylet/needle combinationas connected for utilization within the disclosed device.

FIG. 32B is a side perspective view of the stylet/needle combination asconnected for utilization within the disclosed device.

FIG. 33 is an exploded side perspective view of a the device of FIG. 24in unfolded, pre-used position.

FIG. 34 is a side perspective view of an IV line/needle combination forintraosseous delivery of medicaments subsequent to utilization of thedisclosed device.

FIG. 34A is an exploded side perspective view of the IV line/needlecombination of FIG. 34.

FIG. 34B is a cross-sectional side view of the IV line/needlecombination of FIG. 34.

FIG. 35 is a side perspective view of another possible embodiment of theoverall device in folded pre-used state.

FIG. 36 is a side perspective view of the device of FIG. 35 in unfoldedpre-use state.

FIG. 37 is a side perspective view of the device of FIG. 36 in unfoldedready-to-use state.

FIG. 38 is a rear perspective view of another possible embodiment of theoverall device in unfolded state after use with cannula disengagementand motor and stylet retracted with the battery removal door opened.

FIG. 39 is a side cross-sectional view of a close-up of the batteryremoval door in opened state as in FIG. 38.

FIG. 40 is a front side perspective exploded view of another possibleembodiment of the overall intraosseous drill device.

FIG. 41 is a close-up cross-sectional side perspective view of therotating connector hub between the barrel and handle of another possibleembodiment of the overall intraosseous drill device in closed position.

FIG. 41A is a close-up perspective view of the rotating connector hub ofFIG. 41.

FIG. 42 is a close-up cross-sectional side perspective view of therotating connector hub between the barrel and handle of another possibleembodiment of the overall intraosseous drill device in open position.

FIG. 42A is a close-up perspective view of the rotating connector hub ofFIG. 41.

FIG. 43 is a side perspective view of another possible embodiment of theoverall device in folded pre-used state including a light and controlswitch on the barrel.

FIG. 43A is a side perspective view of the device of FIG. 43 in unfolded(open) state with the automatic light activation prior to use.

FIG. 43B is a side perspective view of the device of FIG. 43A inunfolded ready-to-use state.

FIG. 44 is a side perspective view of another possible embodiment of theoverall device in folded pre-used state including a light array aroundthe barrel opening and a control switch also present on the barrel.

FIG. 44A is a side perspective view of the device of FIG. 44 in unfolded(open) state with the automatic light activation prior to use.

FIG. 44B is a side perspective view of the device of FIG. 44A inunfolded ready-to-use state.

FIG. 45 is a cross-sectional side perspective view of another possibleembodiment of the overall intraosseous device in unfolded pre-use state.

FIG. 46 is an aerial view of a potential embodiment of a recessedcannula hub in oval shape with wing flaps.

FIG. 47 is an aerial view of the hub of FIG. 46 with the wing flapsopen.

FIG. 48 is a front view of an open barrel embodiment with a stowedstylet protective arm and stowed internal film.

FIG. 49 is a front view of the open barrel embodiment of FIG. 48 withactivated/unstowed stylet protective arm and internal film.

FIG. 50 is a cross-sectional side view of a possible handle embodimentof the overall intraosseous device with a battery removal door having aliving hinge on the rear handle portion in closed state.

FIG. 51 is a cross-sectional side view of the handle of FIG. 50 having abattery removal door with the living hinge in open state.

FIG. 52 is a cross-sectional side view of a possible handle embodimentof the overall intraosseous device with a battery removal door having aliving hinge on the bottom portion in closed state.

FIG. 52A is a cross-sectional side view of the handle of FIG. 50 havinga battery removal door with the living hinge in open state.

FIG. 53 is a side perspective of another possible embodiment of theintraosseous device with a top barrel side status indicators and a lightin a folded pre-use state.

FIG. 54 is a side perspective view of the device of FIG. 53 in anunfolded pre-use state with the light automatically activated.

FIG. 55 is a side perspective view of the device of FIG. 54 in unfolded,ready-to-use state.

FIG. 56 is a side cross-sectional view of the device of FIG. 53 infolded pre-use state.

FIG. 57 is a front side perspective cross-sectional view of theconnector hub electrical components of FIG. 56 in folded pre-use state.

FIG. 58 is a side perspective cross-sectional view of the device of FIG.54.

FIG. 59 is a side perspective cross-sectional close-up view of the rearportion of the barrel and connector hub of the device of FIG. 53 infolded, pre-use state.

FIG. 60 is a side view of the device of FIG. 55 subsequent to usestanding on its own with the light activated and rotated at an angle.

FIG. 61 is a side cross-sectional view of an after-use device inre-folded state as far as it can be manipulated with protective capextender blocking complete closure.

FIG. 62 is an exploded front side perspective view of the device of FIG.55 after use with the cannula and hub separated for placement within apatient bone and the handle and connector hub detached from thesharps-containing barrel.

FIG. 63 is a side cross-sectional view of the barrel end of the deviceof FIG. 62 with the protective extender cap including a door cover overthe retracted stylet point.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Reference now should be made to the drawings, presented as non-limitingpossible embodiments in accordance with the descriptions provided above.The ordinarily skilled artisan would fully understand the breadth andscope intended herein in relation to the following potentially preferredtypes.

It will be understood that, although the terms first, second, third,etc. may be used herein to describe various elements, these elementsshould not be limited by these terms. These terms are only used todistinguish one element from another element. Thus, a first elementdiscussed below could be termed a second element without departing fromthe teachings of the present disclosure.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting. As used herein, thesingular forms “a”, “an”, and “the” are intended to include the pluralforms as well, unless the context clearly indicates otherwise. It willbe further understood that the terms “comprises” and/or “comprising” or“includes” and/or “including” when used in this specification, specifythe presence of stated features, regions, integers, steps, operations,elements, and/or components, but do not preclude the presence oraddition of one or more other features, regions, integers, steps,operations, elements, components, and/or groups thereof.

FIG. 1 depicts the drill 10 with a housing 12, completely enclosing arotatable stylet 16, connected permanently to an implement 18 rotated bya gearbox 20, which is powered by a motor 22. A power source 34 isprovided in the handle 36 thereof, as well. A platform 38 for placementof the gearbox 20 and motor 22 is provided that forces the gearbox 20and motor 22, and thus stylet 16, to slide along a track 24 and isrelated with a spring 50. In non-compressed form, the platform 24 restsas shown, with the stylet 16 tapered end at the tip of a Luer lock 54opening of the cannula 14. The cannula 14 is connected with the drillhousing 12 at an egress opening 44 and is provided in this state priorto and during utilization. Also present within the housing 12 is aspring-based 42 closure 40 internal thereto that is compressed in formas the Luer lock end 54 of the cannula 14 is present within the drillhousing 12.

FIG. 2 shows the compression of the platform 24 moving spring 50 throughexternal pressure to a lever 32 which maneuvers the gearbox 20 and motor22 with the stylet 16 forward along the track 24 such that the stylet 16moves through the cannula 14 bore and out the end thereof in order toprovide a tapered drill bit. The motor 22 includes a connection 26 thataligns with a power source, 28 as well, in order to allow for motoractivation in such a state. The spring 50 connects with a movable latchwith two separate components 46, 48 at such an extending state andremains static until user activation changes such a status. The user maythen place the stylet tip on a target patient's skin (56 of FIG. 3, forinstance) in the area for bone access (58 of FIG. 3) and apply the powerto a switch 29 and the handle that leads to the power component 34through a lead 31 that then leads through a wire 30 to the motor 22 torotate the stylet 16 for such operation until the stylet 16 and cannula14 have reached a selected depth therein.

FIG. 3 provides post-drilling status as the cannula 14 resides withinthe bone 58 and attached to the drill housing 12, but the spring 50 hasbeen delatched (such as through a compressed switch, button, and thelike, or twisting and/or turning of the drill a slight amount to achievethe delatching result) and the platform 24, including the gearbox 20,motor 22, and stylet 16, has retracted, leaving the stylet 16 within theconfines of the drill housing 12 subsequent to the drilling step.

FIG. 4 thus shows the detachment of the cannula 14 from the drillhousing 12 (such as through a twisting or turning motion of the drillitself). The instant such cannula 14 moves sufficiently outward throughthe egress opening 44, the closure 40 springs 42 over such an opening44, thereby encasing the stylet 16 in total. The drill body with stylet16 is thus sealed and may be disposed of while the cannula 14 remains inthe subject patient's bond 58 for introduction of medicaments or removalof fluids, etc., therefrom and therethrough.

FIGS. 5-10 show a different embodiment from that above, with a drilldevice 110 and a housing 112, a stylet 116, a cannula 114, a revolvinghinged handle 136 housing a power supply 134 and having a switch 129, ahinge 133, and an electrical connector 160. The drill body includes afirst closed door 143, a motor 122, a gearbox 120 a drive shaft 119, astylet holder 118, a cannula Luer lock component 152, an opening for thecannula and stylet to exit 144, an electrical connector 162 for thehandle to contact, and a second sealing door 140. In this embodiment, aswell, is a annual controller device 132 to move the cannula 114 andstylet 116 as attached together internally to an external location forskina do bone contact. FIG. 6 shows the handle turning to engageelectrical contacts 160, 162 which activates the initial door 143 toallow egress of the cannula 114 and stylet 116 through the opening 144.The manual controller 132 then moves the handle switch 129 then operatesthe drill to implant the cannula 114 within a patient's bone (58 of FIG.3). FIG. 9 shows the internal portion of the drill body with acompressed spring 121 that engages to retain the stylet 116 in place forthe drill operation. A compressed door spring 142 awaits activation uponretraction of the stylet spring 121 to seal the opening (144 of FIG. 5)as well. The actual Luer lock 154 is shown to allow the needed accessfor intravenous, etc., utilization after implantation within a subjectpatient bone, as well. The drive shaft 119 provides the necessaryrotation of the stylet 116 and attached cannula 114 during operationwith the stylet storage tube 118 awaiting final disposition thereinafter utilization. FIG. 10 shows the disengagement of the cannula 114from the drill housing and the sealed door 140 in place. As well, thestylet 116 has been retracted and sealed within the tube 118 fordisposal thereof.

FIG. 11 provides a multi-sided taper 117 of the stylet 116, but witheven edges thereover, and an even multi-tooth 115 cannula 114 edge belowsuch a taper 117 configuration of the stylet. This overall configurationprovides an effective drilling capability, particularly through bone. Ofcourse, any functional design and configuration would be permittedwithin these structures.

FIGS. 12-14 show a close-up of the interface of cannula base 152 andinternal assembly base rotatable component 170. The arms 166 thereof therotatable base extend perpendicular and then again upward with flangesthat are complementary to notches 164 within the cannula base 152. Heretwo opposing arms 166 are present to accord directional torque whenengaged with further flanges 168 preventing the cannula 114 from movingaway from the base assembly 152 during use. With a turn (eitherdirection clockwise or counter-clockwise, depending on how theconfiguration is provided) the base assembly arms 166 are removable fromthe cannula base 152, allowing for the cannula 114 to remain in a targetpatient's bone and skin while the drill device, and the internalassembly including the stylet, retract back. The Luer lock 154 is thuspresent to provide the connections needed for medicament delivery and/orfluid, etc., removal from such a bone.

FIGS. 15-18 show another potentially preferred embodiment with a devicethat may be operated with a single hand, opened, aimed, drilled, andsealed (and possibly separated from its handle) easily and safely. Thedrill device 210 includes a drill housing 212, a handle 236, a hinge 233at the handle/drill housing interface, grips for handling 276, a handleswitch for operation 229, a stowed cannula/stylet cover 272, a cannula214 and stylet 216, a cannula attachment 254, a cannula holder 253, anda drill housing opening 244. The cannula 214 and stylet 216 stows in thecover 272 until the caregiver/user opens the handle 236 through thehinge 233 (a button, release component, etc., may be employed for such apurpose) with the cover 272 protecting from piercing, etc., and keepingthe cannula 214 and stylet 216 protected from infection, etc., prior toutilization. Upon opening, the cannula 214 and stylet 216 are thusavailable for utilization (implantation/insertion within a patient'sbone). The switch 229 is activated to start the drilling action. FIGS.19 and 19A show differing views of the cross-sectional internalcomponents thereof, with a slide track 224 to permit the retraction ofthe stylet 216. A compressed spring 250 awaiting disengagement for sucha purpose. A motor 218 to provide torque and a drive shaft 220permanently attached to the stylet 216. A spring-loaded component 22 ispresent to operate the sealing door (240 of FIG. 20B), as well. Thedrill housing 212 includes a hinge connector 280 to permit disengagementthrough the hinge nut 233, as well.

FIGS. 20 and 20A show the retracted stylet 216 upon disengagement fromthe cannula 214 and retraction of the spring 250 to cause such an action(slide along the track 224 of FIG. 19, for instance). The power supply234 in the handle 236 provides the needed electrical charge to providethe motor 218 to operate and the drive shaft (223 of FIG. 21B), as well.The disengagement of the stylet 216 may be through rotation of the drillhousing 212 after introduction of the cannula 214 and stylet 216 withina subject patient's bone. Upon retraction, then, FIG. 20B shows thesealing door 240 over the drill housing opening 244 to keep the usedstylet 216 therein safely. The springs 220 activate upon reaction of thestylet 216, as shown in FIGS. 20 and 20A, as well.

FIGS. 21 and 21B show the connection of the cannula 214 and stylet 216with the permanently attached motor shaft 223, as well. The cannulacover attachment 253 includes therein the needed Luer lock 254 forutilization with IVs, etc., after implantation. FIG. 21A shows theseparation of cannula 214 and stylet 216, as well, with the Luer lock254 accessible.

FIG. 22 thus shows the sealed door 244 over the drill housing opening240 and the separation of the handle 236 through the hinge nut 233disengagement from the drill housing connection 280 and the handleconnection 281 (from the opening thereof 283). The sealed drill housingmay thus be disposed of (such as within a sharps container, or the like)and the handle may be disposed of separately. Such separation allows forthe smaller profile devices to be disposed of as needed, particularly ifbatteries and other power devices are not permitted within sharpscontainers.

Thus, with this type of device, of which this is merely one possibleembodiment, of course, there is provided a totally passive safetyprocedure for intraosseous activities. In addition, the entirety of thedrill may then be disposed of to further reduce, if not remove, anypotential for contamination thereafter externally. The drill may furtherbe provided within a hermetically sealed enclosure prior to actualutilization with the cannula in place and the only requirement being thespring movement to introduce the stylet for drilling purposes throughthe cannula bore. Additionally, there may be provided a battery/motor(or other component) separator to ensure, as best possible, the powersupply is not depleted prior to actual removal from such an enclosure.Thus, a tab, for instance, of plastic (which may be the same plastic asfor the enclosure itself), may be integrated within the enclosurestructure to act as such a separating component. Upon opening theenclosure, then, the separating component automatically disengagesbetween power supply and other component, thus allowing for theconnection to then flow electricity as needed.

The cannula may also be provided herein as a MRI-safe metal to permitsuch a subsequent activity without the need to remove and introduceanother one after such an action is undertaken.

FIGS. 23-31 show another potentially preferred embodiment of thedisclosed passive safety intraosseous device. The device 310 includes abarrel 312, a handle 314, a connection hub 316, a drill switch 322 onthe handle 314, a sled slide opening 317, slide grips 318, and a barrelopening 326. The device in FIGS. 23 and 26 are shown with the handle 314and barrel 312 in stowed (folded) position with the end of the handle314 covering most of the barrel opening 326. As the handle 314 andbarrel 312 and unfolded, as in FIGS. 24, 25, 27, and 28, the drillswitch 322 is made available (in this embodiment it is present on thehandle 314) and the connection 324 between handle 314 and barrel 312 isshown as well. FIGS. 25 and 28 thus further show the extension of thestylet 330 and cannula 328, as well as the cannula hub 332, through thebarrel opening 326, thus allowing for the device 310 to be inready-to-drill state. FIGS. 29 and 29A show the device 310 inprior-to-use state with the handle 314 and barrel 312 unfolded, but thestylet 330 (and thus cannula 328, of FIG. 28) still within the barrelhousing 312. The slide grip 318 is in its initial state at the rear ofthe barrel 312, as a result. Further shown are the motor 340 the spring334 and the cannula 328 and hub 332 through the side opening 336 of thebarrel 312. FIGS. 30 and 30A show the extension of the cannula 328 andstylet 330 for ready-to-use status of the device 310 with the slide grip318 moved to the other end of the barrel housing 312 and the spring 334compressed as a result. FIGS. 31 and 31A show the device 310 inpost-drill state with the cannula 328 and cannula hub 332 free from thestylet 330 as it has been retracted back within the barrel 312 and theintegrated motor 340 as well with the spring 334 extended in reaction tothe disengagement of the stylet 330 and cannula hub 332. The cannula 328and cannula hub 332 would thus be maintained within a target patient'sbone (such as 58 of FIG. 3) and the device then disposed of with theretracted stylet 330 passively moved and stored to prevent any furthercontact after removal from a patient's body.

FIGS. 32, 32A, and 32B provide a close up view of one possibleembodiment of a recessed cannula hub 332 to provide, at first, thestylet 330 and cannula 328 interface (with the stylet 330 shown in thisinstance separated from the integrated motor (340 of FIG. 31, forinstance) solely to allow for suitable view of the two component partsin this manner. Again, in actuality, the stylet 330 is fully integratedand inseparable from the motor (340 of FIG. 31) when in actual usewithin the device (310 of FIG. 23) and separation of the two would causethe device to be unworkable. In this instance, then, the stylet 330 isinserted within he cannula 328 and extends therefrom when nestedtogether (FIGS. 32A and 32B, for example). The hub 332 includes, in thispossible embodiment, two opposing sides in rounded triangular shape(overall a roughly oval shape) 356 that allow for grasping by the user,at least, during drilling operations and retraction of the stylet 330.As shown in FIG. 32, then, the hub 332 includes a recessed opening 352for the stylet base 344 to enter and temporarily connect with throughrotation (as noted above; retraction is accomplished through rotation inthe opposite direction). A bore 354 within the cannula hub leads to thecannula (needle) 328 itself to permit placement of an IV, as one example(as shown in FIGS. 34, 34A, and 34B, for instance) thereon to supplyfluids, etc., external the cannula, therethrough, and into a targetpatient's bone (intermedullary space). The stylet 330 further includes apermanent adapter 340 that connects and secures with an integrated motor(such as, as one example, 876 of FIG. 56) with an end opening forpermanent insertion of a motor shaft extension 358 to turn/spin thestylet 330 (and thus the cannula 328 when connected together), as wellas a side opening 348 for insertion of a permanent connection (such as abolt or like connector that is not removable without damaging either thestylet 330 or the motor) from the motor as well. As shown in FIG. 32A,the cannula hub 332 is complementarily configured with the arms 360 ofthe stylet base 344 to secure as both are spinning in the same drillingdirection. Again, as the stylet 330 and motor are then rotated in theopposite direction, the arms 360 free from the cannula hub opening 352and both retract leaving the cannula 328 within the target patient'sbone and the hub 332 at the target patient's skin surface. Importantly,it is noted that the cannula hub 332 shown within this embodiment is,again, one possible alternative. If the user desires the utilization ofa Luer lock hub, such is of course permitted in such an instance forboth stylet and cannula connection and IV, etc., insertion during fluid,etc., introduction subsequent to bone drilling. FIGS. 34, 34A, and 34Bshow the utilization of a fluid feed line 372 (such as an IV, as oneexample) connected with a recessed cannula hub 332. The line 372includes, in this instance, a curved cover 370 (although it is possibleto avoid any curved cover, certainly, and just have the line feeddirectly, if desired) with a complementary connector 374 with similarstructure internally to the retracted stylet (330 of FIG. 31, forinstance) to attach over the recessed hub internal adapter extensions352 over the cannula opening 354. The feed line 372 thus includesbuttresses 376 to secure with the cannula hub 332, thus, when alignedwith the cannula opening allows from fluid or other materials to enterthe cannula bore 378 for transfer to the target patient's bone.

FIG. 33 provides an exploded view of the disposable nature of theoverall device 310 with the barrel 312 including the opening 326,opposing circular rotating cavities 324, circular aligned connectionwith the handle 364, the slide grip 318, the slide grip access and pathopening 317 and a closed stylet point protective arm 350. Additionally,there is present the handle 314, with the switch 322, and complementarycircular cavity 366 for rotation purposes, and, separately, theconnection hub 316, that is removable to allow for such barrel 312 andhandle 314 separation. The barrel 312 with the stylet point therein maybe disposed of as a “sharp” within an appropriate container and thehandle 314 and connection hub 316 may be disposed of in a standardrubbish bin or, if necessary, due to the potential for blood and/orother bodily fluid(s) thereon after utilization, may be disposed ofwithin a suitable biohazard container. In any event, such separability,easily attained through the disconnection and disengagement of theconnection hub 316 accords such beneficial results.

FIGS. 35-39 and 45 show another potentially preferred embodiment of thedisclosed passive safety intraosseous device. The device 400 includes abarrel 412, a handle 414, a connection hub 416, a drill switch 420 onthe barrel 412, a sled slide opening 417, slide grips 418, a barrelopening 426, a bottom handle foot 417, and a battery removal door 415 atthe bottom of the handle. The device in FIG. 35 is shown with the handle414 and barrel 412 in stowed (folded) position with the end of thehandle 414 covering and facing most of the barrel opening 426 (and thebottom handle foot 417 facing outwardly. As the handle 314 and barrel312 and unfolded, as in FIGS. 36 and 37, the drill switch 420 is madeavailable (in this embodiment it is present on the barrel 412) and theconnection 424 between handle 414 and barrel 412 is shown as well. FIG.37 thus further shows the extension of the stylet 430 and cannula 428,as well as the cannula hub 434, through the barrel opening 426, thusallowing for the device 400 to be in ready-to-drill state. The bottomhandle foot 417 is flat with, in this embodiment, a rounded triangularshape (of course, if desired, such a shape may be of any geometric type,including rounded, ovular, squared, and the like) to accord, with theflat, planar structure of the battery removal door 415 of the handle414, the ability for the device to stand hands-free on a flat surface,if desired.

FIG. 37, again, shows the extension of the cannula 428 and stylet 430for ready-to-use status of the device 400 with the slide grip 418 movedto the other end of the barrel housing 412 and the spring (such as 334of FIG. 30) compressed as a result. FIG. 38 shows the device 400 inpost-drill state with the cannula 428 and cannula hub 434 free from thestylet 430 as it has been retracted back within the barrel 412 (with, asbefore the integrated motor, such as 340 of FIG. 30, as well as thespring, such as 334 of FIG. 31, extended in reaction to thedisengagement of the stylet 430 and cannula hub 434). The cannula 428and cannula hub 434 would thus be maintained within a target patient'sbone (such as 58 of FIG. 3) and the device then disposed of with theretracted stylet 430 passively moved and stored to prevent any furthercontact after removal from a patient's body. FIG. 45 shows the unfolded,prior-to-use status of the device 400 as above, with the batteries 423shown as stored within the handle 414, with the cannula 428 and cannulahub 434 within the barrel 412 and the stylet 430 extending therefrom butalso permanently attached to the motor and covered internally with aheath 437 to add in reducing moisture ingress within the barrel 412 andprotection of the motor at least. Also shown is a rear gearbox coverattached to the slide grip 418 and attached to the spring 436, as well.The switch 420 further shows a contact 438 to maneuver upon compressionof the switch to further create the needing conduction of electricity asneeded for motor activation and operation on demand. itself

FIG. 38 shows a rear perspective view of the post-use unfolded state ofthe device 400 of FIGS. 35-37 with the sled grips 418 returned in rearposition on the barrel 412 subsequent to stylet/motor retraction. Priorto disposal thereof, then, the battery removal door 415 is disengaged topermit such battery access. FIG. 39 shows a close-up cross-sectionalside view of the lower handle 414 and battery removal door 415 as wellas the bottom handle foot 417. The door 415 is provided with a roundedbottom edge 431 to allow for gripping by the user with a tab/snapconnector 429 at the front thereof that is complementary in shape to aextension 425 within the internal portion of the bottom handle foot 417.The handle 414 includes a further internal extension 427 to connect withan opening 433 above the rounded edge 431 as they are, as wellcomplementary in shape. The batteries 423 (such as, as noted above, twolithium 9-volt batteries) are thus accessible for simple removal ondemand and the door 415 may be replaced thereafter with reconnection ofthe tabs and extensions 433, 427, 429, 425.

FIG. 40 provides an exploded view of the disposable nature of theoverall device 400 of FIGS. 35-39 with the barrel 412 including theopening 426, a circular aligned connection with the handle 430, theslide grip 418, the drill switch 420, and the slide grip access and pathopening 417. Additionally, there is present the handle 414 with batteryremoval door 415 and bottom handle foot 417, as well as a complementarycircular cavity 432 for rotation purposes, and, separately, theconnection hub 416, that is removable to allow for such barrel 412 andhandle 414 separation. The barrel 412 with the stylet point 430 thereinmay be disposed of as a “sharp” within an appropriate container and thehandle 414 and connection hub 416 may be disposed of in a standardrubbish bin or, if necessary, due to the potential for blood and/orother bodily fluid(s) thereon after utilization, may be disposed ofwithin a suitable biohazard container. In any event, such separability,easily attained through the disconnection and disengagement of theconnection hub 416 accords such beneficial results. In this embodiment,it is also noticed that the connection hub 416 includes a surfaceextension 429 to prevent movement of the hub 416 from the alignedcircular openings 430, 432 of the barrel 412 and handle 414,respectively, until the user manipulates the connection hub 416 throughdepression (or compression) of a pressure tab 439 externally. Such maybe undertaken through pressing the connection hub 416 inward on eitherside of the handle 414 or barrel 412 when in an unfolded state and thenturning the connection hub 416 to maneuver the tab extension 429 from adetent within the handle opening 432 and/or barrel opening 430. In anyevent, this allows for both rotation of the barrel 412 and handle 414 ondemand, full ex FIG. 43 tension to a “locked in” position (and thusfree-standing device on a flat surface, if desired), and eventual facileseparation of handle 414 and barrel 412 for disposal purposes.

FIGS. 41, 41A, 42, and 42A provide a close-up side cross-sectional viewof the connection hub 416 and the circular openings 430, 432 of thehandle 414, and barrel 412. In stowed, folded, position, as in FIG. 41,the connection hub 416 is present in a certain disposition. Such a hub416 actually remains in a static state as, in FIG. 42, the handle 414 isrotated to an open, unstowed position with the inner handle circularopening portion 454 rotated as the barrel opening 432 remains static.The hub (or otherwise referred to as pin herein) 416 includesindentations 460, 461 on opposing sides as well as a spring nub(extension) 452 at the top thereof. The inner handle circular openingportion 454 includes two indentations 453, 460, as well, that arecomplementary in shape to the spring nub 452. As shown in FIGS. 41 and41A, the handle 414 and barrel 412 are folded up in stowed formationwith the inner handle circular opening portion 454 in its own stowedconfiguration and position with the first indentation 453 aligned andnested with the hub spring nub 452. The spring nub 452 is configureditself to press down and with the inclined side of the first innerhandle circular opening indentation 453 as it is provided, is able toslide thereunder to allow the circular opening portion 454 to rotatefrom its initial folded, stowed position. Thus, in FIGS. 42 and 42A, theinner handle circular opening portion 454 has rotated about, in thisembodiment about 110 degree from its stowed position, thereby aligningwith the spring nub 452 and engaging the same with the secondindentation 460 to lock (at least temporarily) therewith the nub 452. Inthis manner, only with a sufficient amount of pressure applied to theconnection hub 416 and thus the spring nub 452 will the handle 414disengage from such a “locked” unfolded state and allow the handle 414and barrel 412 to return, at least to a certain degree, back to foldedstate on demand. Again, as noted above and further herein, the abilityto prevent full re-closing (folding back) of the device is preferable asa proper indicator as to the use status of the device itself. If itcannot refold, it would be considered “spent” and thus ready fordismantling and disposal as needed. The frictional properties of theinner handle circular opening portion 454 as it rotates is sufficient,as well, to retain the unfolded state of the device at any angle measurebetween full open (such as, again, about 110 degrees from folded state)to at least about 20 degrees thereof from folded state. In this manner,as shown, for instance in FIG. 60, the device may stand alone,hands-free, on its flat bottom handle surface to allow for, at least,and if present within such an embodiment, a flash light article to helpthe user with visibility, if needed. If also allows for facilitation oflocation of such a device, whether lit or not, in a darkened space afterdrilling operation has occurred.

FIGS. 43, 43A, and 43B, as well as FIGS. 44, 44A, and 44B, showdifferent potentially preferred embodiments of a disclosed intraosseousdevice with different lights included to both aid the user inundertaking a drilling activity, particularly in dark, low visibilityconditions, as well as subsequently thereto, and upon retraction ofstylet/motor within the device and implantation of cannula/needle withina target patient's bone, as a type of standalone flashlight, ifnecessary and/or desired. FIGS. 43-43B show a light 568 supplied withinthe device 500 that further includes a barrel 512, a handle 514, aconnection hub 516, a drill switch 520 on the barrel 512, a sled slideopening 517, slide grips 518, a barrel opening 526, a bottom handle foot517, and a battery removal door 515 at the bottom of the handle. Thedevice in FIG. 43 is shown with the handle 514 and barrel 512 in stowed(folded) position with the end of the handle 514 covering and facingmost of the barrel opening 526 (and the bottom handle foot 517 facingoutwardly). As the handle 514 and barrel 512 and unfolded, as in FIGS.43A and 43B, the drill switch 520 is made available (in this embodimentit is present on the barrel 512) and the connection 524 between handle514 and barrel 512 is shown as well. As the device 500 is thus unfolded,the light 568 automatically activates, thus providing a means forvisibility, as well as a way of indicating the power within the device500 is functioning properly for drilling purposes. FIG. 43B thus furthershows the extension of the stylet 530 and cannula 528, as well as thecannula hub 534, through the barrel opening 526, thus allowing for thedevice 500 to be in ready-to-drill state; with the light 568 shining,the user, again, knows the power is sufficient for drilling and alsohas, again, a means to light the desired drilling location as needed.The bottom handle foot 517 is flat with, in this embodiment, and asabove, a rounded triangular shape to accord, with the flat, planarstructure of the battery removal door 515 of the handle 514, the abilityfor the device to stand hands-free on a flat surface, if desired,particularly subsequent to drilling to permit a user hands-freeutilization of the flash light capability of the device 500 thereafter.

FIGS. 44, 44A, and 44B are similar to FIGS. 43-43B except in thisembodiment there is in place a full array of lights 668 around theperiphery of the barrel opening 626. Certainly, as alluded to above,such an array may be anywhere from 2 to as many as 12 lights, if desired(although with 2, one may be on the bottom and one at the top of theperiphery, with 4 in each cardinal location thereof, etc., and providesufficient and proper lighting and indications of power generation forthe user). In this situation, the same basic device 600 is provided witha barrel 612, handle 614, battery removal door 615, bottom handle foot617, slide opening and spring 617, slide grips 618, connection hub 616,handle connector 632, barrel drill switch 620, and barrel opening 626.When unfolded, as above, the lighting array 668 activates for visibilityand power indication for the user; upon extension through movement ofthe slide grip 618 towards the front of the barrel housing 612, thecannula 628, with hub 634, and stylet 630 extend as well for drillingaccess. As with the other embodiments noted above, the extension of thecannula 628 and stylet 630 provides a for ready-to-use status for thedevice 600 with the slide grip 618 moved to the other end of the barrelhousing 612 and the spring (such as 334 of FIG. 30) compressed as aresult. Similar to that shown in FIG. 38, above, subsequent to drilling,the stylet/motor retracts leaving the cannula within a target patient'sbone, and the device ready for disposal thereof, again, as noted above.

FIGS. 46 and 47 provide aerial views of one possible embodiment of acannula hub in oval-like shape. The hub includes grip sides 356 withstowed wing blades 369. Centrally located are the cannula opening 354and the stylet and/or IV (or other connection) opening 352. In FIG. 47,the wing blades 369 are unstowed, particularly after introduction withina target patient's skin and bone, in order to allow for tape-downthereof for a more secure introduction of the cannula as needed.Certainly, as noted above, the cannula hub may be of any geometric shapeand the wing blades may as well. This embodiment merely shows onepotential manner of supplying such appendages to the cannula hub fortape-down, etc., purposes.

FIGS. 48 and 49 show a close-up of a potential embodiment of a barrelopening 326 (as in FIG. 33) including a stowed stylet point protectivearm 338 that extends, in FIG. 49 half way within the opening 326 tocover the stylet point (330 of FIG. 31, for instance) after retractionthereof. Also included, as another added benefit, and in order topotentially protect a user from not only the stylet point, but anypossible fluids brought within the barrel opening 326 upon retraction,is a spreadable cover film 339 that stows along the sides of the barrel350 prior to retraction of the motor/stylet. Once retraction occurs, thefilm moves with the arm 338 to cover the portions of the opening 326 notcovered by the arm 338. Other embodiments allow for further covers,doors, and the like, as alternatives to this possible variation as well.

FIGS. 50, 51, 52, and 52A show alternatives to the battery removal doorshown above, particularly as a means to allow for disposability of fullyconnected parts that would be unitary n nature as disposed of together.As shown above, a removable battery door (415 of FIG. 45, for instance)may be employed and allows for access to batteries for removal anddisposal separately as needed. Such a door, however, in the user'shaste, may be thrown away separately, leaving such disposability of morethan one part. If such a device is particularly stained or contaminatedwith body fluids, etc., of a target patient, the ability to ensurelimited numbers of such device parts are placed in necessary containers,etc., for safety purposes would be potentially important. As such, andmerely as potential embodiments of such single structure items,disposable handles 714 with connection hub openings 732 are shown withinsuch FIGS. 50-52A as including living hinge battery removal openings. InFIGS. 50 and 51, the door 715 has a rear handle placed living hinge 727that allows for disengagement at the lower front of the handle 717 andlower rotation to allow unfettered access to the batteries 723. In thismanner, the height of the opening 715 allows for easy grasp of suchbatteries 723 (again, preferably here lithium 9-volt types) on demandfor removal. In FIGS. 52 and 52A, the door 735 is at the bottom of thehandle 714 and the living hinge 737 is present at the lower rear portionof the handle 714, thus allowing for opening of the full bottom of thehandle 714 at a lower rear point. This allows for battery 723 access,certainly, with the further possibility of utilizing a drape fabric 740(or plastic, as desired) to provide further capability of pulling downon the batteries 723 for removal, if needed. Certainly, as noted aboveand herein, such batteries may be stowed within the handle with theability for wires attached through snap-on contacts that can themselvesextend upon opening of such doors (since the batteries 723 rest on thedoors themselves) and the batteries 723 may thus simply be removed fromsuch contacts and removed. In either situation herein, the doors 715,735, may be closed after battery removal, or left open. Being connectedof the handle 714, such doors 715, 735 are thus part of a unitarystructure for proper disposal purposes after battery removal.

FIGS. 53, 54, and 55 provide a device 800 with a number of differentstructural components for another potentially preferred embodiment. Inthis alternative, an intraosseous device 800 is provided with a barrel812, handle 814, battery removal door 815, bottom handle foot 817, slideopening and spring 817, slide grips 818, connection hub 816, barreldrill switch 820, and barrel opening 826. Additionally, as shown in FIG.55, there is an extended motor/stylet housing 899 for at least space tograsp the cannula hub 834 during use. The cannula hub 834, furtherincludes wing blades 835 and the device includes a light 894 in thebarrel opening 826. Additionally, the extended motor/stylet housing 899includes a top-disposed tab 819 that resides within a rear-disposedbarrel top opening 821 when stowed prior to extension of themotor/stylet/cannula and slides with the motor/stylet/cannula upon gripslide 818 movement towards the from the barrel housing 812. Thetop-disposed tab 819 then moves to a front-disposed barrel top opening823. The tab 819 is structured with a flat side disposed at the rearportion thereof and an incline leading downward to the front portionthereof. This structure allows for the rear tab portion to lock in placewithin the front-disposed barrel top opening 823 and slide forward fromthe rear-disposed barrel top opening 821 upon movement of the slide grip818 and slide compression 817. In this manner, the extended motor/stylethousing remains in place as it is extended even after retraction of themotor/stylet subsequent to drilling operation. As shown in FIGS. 60, 61,and 62, for instance, the extended housing 899 remains outside thebarrel opening 826 when and after retraction occurs. As in FIG. 61,then, the extended housing 899 prevents re-closing of the handle 814 andbarrel 812 together, indicating the device has been “spent” and disposalis needed at that time. The housing tab 819 further provides indicationof a “spent” device as the user may view the presence of the tab withinhe front-disposed barrel top opening 823 as such a communication thatthe device has been utilized (particularly if no cannula and/or hub arepresent external the barrel simultaneously as being checked). As notedabove, the openings 821, 823 may be provided with color coding, orworking, etc., as desired, as an explanation as to the status of thedevice, with the presence of the tab 819 within the rear opening 821indicating ready-to-use, and, again, in the front opening 823, denotinga “spent” device and need for disposal thereof properly. In any event,as above, for FIGS. 44-44B, for example, the lighting array 868activates for visibility and power indication for the user when thehandle and barrel are unfolded (even to just a minimal rotationaldistance, such as, for example, about 20 degrees from stowed state, tofull extension). When fully extended, and thus ready to activate thedrill component, the slide grip 818 may be maneuvered along the springopening and guide 817 towards the front of the barrel housing 812, thusmoving the motor/stylet/cannula component 828.830, with wing-bladed hub834, outwardly for drilling access. As with the other embodiments notedabove, the extension of the cannula 828 and stylet 830 provides a forready-to-use status for the device 800 with the slide grip 818 moved tothe other end of the barrel housing 812 and the spring (such as 334 ofFIG. 30) compressed as a result. Similar to that shown in FIG. 38,above, subsequent to drilling, the stylet/motor retracts leaving thecannula within a target patient's bone, and the device ready fordisposal thereof, again, as noted above. Certainly, it should be wellunderstood that such an embodiment may also include a light or lightarray as described herein, if desired, thus allowing for the fullutilization of such an internal housing extender with a cannula hub,etc., for improved grasping and visibility, as desired.

FIG. 56 shows a full cross-sectional side view of a potentiallypreferred embodiment of the disclosed intraosseous device with a closerview of the electrical configurations therein. The device 800 includes alight 894 with a wire 892 leading to a barrel contact 881. The handle814 includes batteries 823 (preferably, as previously noted, 9-boltlithium batteries) that supply power to an internal handle contact 879that is attached to a electrical contact plate 880 for rotationalcontacting with the barrel contact 881. The electrical conductance fromthe handle 814 (and thus batteries 823) through the handle contact 879and plate 880, occurs upon such rotational movement (unfolding) of thehandle 814 from the barrel 812. In FIG. 58, the full unfolded state ofthe device 800 is shown, with the light 894 automatically activated uponelectrical conductance initiation. FIG. 60 thus indicates that suchconductance may be achieved at 20 degrees from folded state of thedevice 800 and FIG. 58 indicates full unfolding (up to about, forinstance 110 degrees from folded state) with the light 894 activated andthe device 800 in ready-to-use state prior to extension of themotor/stylet/cannula for drilling operations. In FIG. 56, the device 800includes the drill switch 820 with connector component 838 and contactprongs 884 for wire engagements. As noted above, the light wire 892connects at the barrel contact 881 and leads through the switch 820 butis not activated by the switch 820 at all, only upon electricalconductance from the handle contact 879 and plate 880 to the barrelcontact 881 and thus the light wire 892. Additionally, a curved contact881 is situated within the barrel 812 to lead between barrel contacts881, 883 for continuous electrical conductance when properly alignedwith the handle contact 879 and plate 880. The handle 814 includes abattery removal door 815 for disposal of the batteries 823 when neededas well as the bottom handle foot 817 at the front thereof to aid instabilized stand-alone status of the device (as in FIG. 60, forinstance. The device 800 includes a connection hub 816, as above, forsuch a rotational benefit (to allow for folded and unfolded statuses ofthe device 800) as well as to separate the barrel 812 from the handle814 for disposability, again, when needed. The switch 820 activateselectrical conductance from the barrel contacts 881, 883 to the motorwire 873 that leads to the motor 876 with the stylet base 870permanently attached thereto and leading to the stylet 830 extendingfrom the cannula 828. The cannula hub 834 is contacted, temporarily,with the stylet 830 through arms 878 aligned with openings 887 in thehub 834. The motor 875 is connected with a rear gear box 875 and all ofthe gear box 875, motor 876, and stylet 830 are not only integratedtogether as a single unit, but are covered by an internal housing 837that has a peripheral edge 899 that contacts the bottom edge of thecannula hub 834 (in this embodiment) and further includes anautomatically pivoting cover/door 900 (that covers the stylet 830 afterretraction as shown in FIG. 61, as one example). Additionally, theinternal housing 837 includes a top positioned tab 819 that is inclinedwith a rear-facing flat surface and aligns with the barrel top openings821, 823, as noted previously. In FIGS. 56, 58, and 59, the tab 819 isaligned in the rear tab barrel top opening 821, awaiting movement withthe extension of the motor/stylet/cannula through the slide grip 818manipulation outwardly from the barrel opening 826. The internal housingextender 837 prevents further movement of the motor/stylet thereunder asthe extender 899 stops at the barrel opening 826 and the cannula hub 834and cannula 828 (as well as the stylet 830 pre-retraction) are thenaccessible external of the device 800 for drilling purposes. The spring872 thus allows for such retraction on disengagement of the cannula hub834 and stylet base arms 878, as described in greater detail above. Thecannula hub 834 further includes wing blades 835 folded thereon untilunfolded (as in FIG. 62, for example). A spring 872 encircles themotor/stylet/gearbox 876, 830, 875 to retract the same assembly afterdrilling operation is complete (and the cannula 828 and hub 834 areintroduced within a target patient's bone and the wing blades 835 aredeployed on the patient's skin). FIG. 57 provides a rear perspectiveclose-up cross-sectional view of the electrical components at the barrel812 and handle 814 interface as described above. The switch 820 leads toa connector component 838 to wire connecting prongs 884. The handleincludes a handle contact 879 and a contact plate 880 for connectionwith the barrel contact 881 that leads to the curved contact 882 and thefurther barrel contact 883 that is ultimately associated with the motorwire and (873 of FIG. 56, for instance) the controlling switch 820 forsuch drilling operation.

FIGS. 58 and 59 provide cross-sectional side views of the device of FIG.56 in unfolded prior-to-use state. Thus, the same a potentiallypreferred embodiment of the disclosed intraosseous device 800 is shownwith the light 894 activated due to the connection of handle contact 879and plate 880 with the barrel contacts 881, 883 and curved contact 882in response to the rotation of the handle 814 around the connection hub(pin) 816 in relation to the barrel 812. with a closer view of theelectrical connections therein. The internal housing extender 839

FIG. 60 shows the functionality of a potentially preferred lightedintraosseous device subsequent to drilling operation as a free-standingflash light article. The spring 872 has expanded to deliver themotor/stylet automatically upon disengagement with the cannula hub andthus retraction has occurred (the slide grip 818 returns to its originalposition, as well along the slide opening 817). The internal housingextender 899 remains external the barrel opening 826, the internalhousing tab 819 is present and engaged with the barrel top front opening823 to ensure the housing (837 of FIG. 56, for instance) remains inplace with the front extender 899 outside the barrel opening 826. Thebarrel 812 thus can rotate around the connection pin 816 with the usersimply disengaging the spring nub (452 of FIG. 41A, for example) andmoving the barrel 812 around such a pin in relation to the handle 814which may be placed on a flat surface with the flat battery removal door815 and the bottom handle foot 817 providing a reliable base for such apurpose. The rotation of the barrel 812 may be from full extension(unfolded state, again, roughly 110 degrees from folded state) to nearlyclosure (as shown in FIG. 61, the internal housing extender 899 preventsfull closure thereof), as desired. With the electrical connections(handle contact 879 and plate 880 and barrel contacts 881, 882, 883) inplace, the light 894 remains activated permitting utilization thereof asa flash light device itself; the flat surface placement allows forhands-free placement thereon and the rotation of the barrel 812 allowsfor directional provision of the light 894 as needed and/or desired forthe user. Such rotation of the barrel 812 may be as low as, in thispotential embodiment 20 degrees from folded state and still remainconnected for electrical conductance from the batteries 823 to the light894 for operation thereof. As noted above, FIG. 61 shows the fullyretracted state of the motor 876, gearbox 875, and stylet 830 backwithin the barrel 812 with the internal housing cover 837 remaining atthe front end thereof the barrel 812 with the internal housing top tab819 secured within the barrel top front opening 823 to prevent movementof the internal housing 837 back as retraction occurs. Thus, the housingextender 899 outside the barrel opening 826 to prevent full closure ofhandle 814 bottom foot 817, for instance, back over the barrel opening826 as originally provided prior to unfolding and drill operation. Thespring 872 has thus extended back to its desired position to retract theinternal components as noted and the housing extender cover 900 hasclosed over the stylet 830 automatically once the retraction step occursto prevent any external contact with the stylet point 830 by the user oranyone else. FIG. 63 provides a closer view of the barrel opening 826after retraction of the stylet 830 (and integrated motor, of course)with the automatic internal housing extender cover 900 deployed over thestylet 830, the internal housing top tab 819 locked within the barrelhousing front top opening 823, the spring 872 extended for suchretraction results, and, with the folding of the device in FIG. 61undertaken past the threshold point for electrical conductivity tooccur, the light 894 is no longer activated. Thus, both FIGS. 61 and 63show a device ready to be disposed of properly subsequent to dismantlingof the barrel 812 and handle 814 and connection pin (hub) 816. FIG. 62provides such separation with the cannula 828 and cannula hub 834 withdeployed wing blades 835 (for skin application while the cannula/needleis within the target patient's bone) and thus the retracted motor/styletwithin the barrel 812 with the internal housing extender 899 in place atthe barrel opening 826. Again, the internal housing top tab 819 providesboth a manner of preventing retraction of the internal housing extender899 back into the barrel 812 as well as an indicator that the device 800has been “spent” in terms of drilling operations. The connection hub(pin) 816 is thus disengaged from both the barrel 812 and the handle 814through pressing in thereof when properly aligned within the circularopenings 832, 867 of the handle 814 and barrel 812, respectively andoperating spring nub 865 as needed to maneuver the connection hub (pin)816 from such aligned components 832, 867. Thus, upon such hub/pin 816removal, the barrel 812 and handle 814 are separated and proper disposalmay be undertaken of both (as well as the batteries within he handlebattery removal door 815, of course).

With the disclosures set forth herein and above, an entire intraosseousdevice having full passive safety capabilities from initial transport,opening for use, unfolding, extension of stylet/cannula, drillingoperation, retraction of stylet (with integrated motor) and thusplacement of cannula within a target patient's bone, and separation anddisposal of all device parts as needed is provided. A light display maybe present for visibility and power generation indication purposes, andthe device may be provided as a stand-alone light providing device forthe user subsequent to drilling and with a light to aid in sight beforeand during such an activity, as well. Indications as to status ofusability are provided, as well, and as needed, to ensure a user knowsat all times whether a device is ready for use or not, too. In otherwords, a full consideration and provision of a passive safetyinatraosseous device with numerous beneficial added implements, and allwith a single-use fully disposable drill accords the emergency medicalindustry a long sought-after advancement that meets a plethora of needsand desires.

Although specific embodiments of the invention have been disclosed,those having ordinary skill in the art will understand that changes canbe made to the specific embodiments without departing from the spiritand scope of the invention. The scope of the invention is not to berestricted, therefore, to the specific embodiments, and it is intendedthat the description herein cover any and all such applications,modifications, and embodiments within the scope of the presentinvention.

What is claimed is:
 1. A single-use, disposable intraosseous drilldevice, said device comprising a foldable combination of a separablebarrel and handle with a connector allowing rotation thereof in relationto one another, said barrel having an open end and a closed end andcomprising a single-structure motor and stylet assembly therein that ismovable through utilization of a manual external implement within saidhousing from a location at or near said closed end towards said openend, wherein said motor/stylet assembly further including a detachablecannula attached thereto having a bore through which said stylet extendsinto and externally from, wherein said motor/stylet assembly includes aretracting component to automatically return said motor/stylet assemblyback towards said closed end of said barrel upon detachment from saidcannula, and wherein said handle comprises a power source to generatesufficient power for operation of said drill through said motor.
 2. Thedevice of claim 1 wherein said handle exhibits a flat foot structurethat allows said device to stand freely on a flat surface.
 3. The deviceof claim 1 wherein said power source comprises at least one battery. 4.The device of claim 3 wherein said at least one battery is selected fromlithium and alkaline battery types.
 5. The device of claim 4 whereinsaid power source is two 9-volt lithium batteries.
 6. The device ofclaim 1 wherein said device generates power as the barrel and handle areunfolded.
 7. The device of claim 1 wherein said device comprises atleast one LED light at the open end of said barrel.
 8. The device ofclaim 6 wherein said device comprises at least one LED light at the openend of said barrel.
 9. The device of claim 8 wherein said at least oneLED light provides an indication of power upon unfolding of said barreland said handle.
 10. A method of introducing substances into and/orremoving substances from a target intramedullary space of a boneutilizing the device of claim 1, said method comprising the steps of: a)providing said device; b) determining the properly located bone portionfor introduction thereof said stylet/cannula of said device; c)activating said device to drill said stylet/cannula therein untilreaching the desired depth within the intermedullary space of said bone;d) deactivating said drill once said depth is reached, therebyactivating the retracting mechanism thereof thereby decoupling saidstylet from said cannula and retracting said stylet into said drillwithin a retraction port therein; e) placing said drill/retracted styletimplement within a disposable container; f) utilizing said retainedcannula for introduction or removal of said substances.